Atlas FDA

V60 VENTILATOR, MODEL V8000

FDA 510(k) clearance K082660 · decided 2009-01-09

Clearance details

K-number
K082660
Device name
V60 VENTILATOR, MODEL V8000
Applicant
Respironics California, Inc.
Decision
Substantially Equivalent
Date received
2008-09-12
Decision date
2009-01-09
Days to decision
119 days
Clearance type
Traditional
Product code
MNT
Device class
2
Regulation number
868.5895
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Carlsbad, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be use recall (Z-0902-2021)Respironics California, LLC2021-01-22
Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be use recall (Z-0903-2021)Respironics California, LLC2021-01-22
Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be use recall (Z-0904-2021)Respironics California, LLC2021-01-22
Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be use recall (Z-0905-2021)Respironics California, LLC2021-01-22
Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be use recall (Z-0906-2021)Respironics California, LLC2021-01-22
Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be use recall (Z-0907-2021)Respironics California, LLC2021-01-22
Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be use recall (Z-0908-2021)Respironics California, LLC2021-01-22
Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be us recall (Z-0909-2021)Respironics California, LLC2021-01-22
Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be us recall (Z-0910-2021)Respironics California, LLC2021-01-22
Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be use recall (Z-0911-2021)Respironics California, LLC2021-01-22
Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be use recall (Z-0912-2021)Respironics California, LLC2021-01-22
Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to b recall (Z-0913-2021)Respironics California, LLC2021-01-22
Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be use recall (Z-0914-2021)Respironics California, LLC2021-01-22
Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to b recall (Z-0915-2021)Respironics California, LLC2021-01-22
Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be u recall (Z-0916-2021)Respironics California, LLC2021-01-22
Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be use recall (Z-0917-2021)Respironics California, LLC2021-01-22
Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, recall (Z-2061-2017)Respironics California Inc2017-05-18
Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85 recall (Z-1537-2013)Respironics California Inc2013-06-17
V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Venti recall (Z-2260-2012)Respironics California Inc2012-08-31
Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA. recall (Z-0457-2011)Respironics California Inc2010-11-24
RESPIRONICS V60 VENTILATOR recall (Z-0176-2010)Respironics California Inc2009-11-11