Atlas FDA

OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR

FDA 510(k) clearance K033973 · decided 2004-12-13

Clearance details

K-number
K033973
Device name
OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR
Applicant
Nellcor Puritan Bennett, Inc.
Decision
Substantially Equivalent
Date received
2003-12-22
Decision date
2004-12-13
Days to decision
357 days
Clearance type
Traditional
Product code
NLF
Device class
2
Regulation number
870.2700
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Pleasanton, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
NELLCOR PURITAN BENNETT INFANT STAR HIGH FREQUENCY VENTILATOR (P880013/S009)Nellcor Puritan Bennett, Inc.2002-12-17
HFV INFANT STAR VENTILATOR (P880013/S008)Nellcor Puritan Bennett, Inc.1998-04-07
HIGH FREQUENCY VENTILATOR (P880013/S007)Nellcor Puritan Bennett, Inc.1997-06-24
HFV STAR (P880013/S003)Nellcor Puritan Bennett, Inc.1993-10-26
HFV STAR (NEW MANUFACTURING SITE) (P880013/S002)Nellcor Puritan Bennett, Inc.1993-08-11
HFV STAR (P880013/S001)Nellcor Puritan Bennett, Inc.1993-02-05
INFANT STAR HIGH FREQUENCY VENTILATOR (P880013)Nellcor Puritan Bennett, Inc.1990-01-19