Atlas FDA

RESPIRATORY HUMIDIFIER, MODEL # MR850

FDA 510(k) clearance K983112 · decided 1998-11-10

Clearance details

K-number
K983112
Device name
RESPIRATORY HUMIDIFIER, MODEL # MR850
Applicant
Fisher & Paykel Healthcare, Ltd.
Decision
Substantially Equivalent
Date received
1998-09-04
Decision date
1998-11-10
Days to decision
67 days
Clearance type
Traditional
Product code
BTT
Device class
2
Regulation number
868.5450
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Auckland, NZ
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit. lntended Use: The dual heate recall (Z-0414-2009)Fisher & Paykel Healthcare Inc2008-12-10
Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Numb recall (Z-0694-06)Fisher & Paykel Healthcare Inc2006-03-29
Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Numb recall (Z-0695-06)Fisher & Paykel Healthcare Inc2006-03-29
Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Numb recall (Z-0696-06)Fisher & Paykel Healthcare Inc2006-03-29
Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Numb recall (Z-0697-06)Fisher & Paykel Healthcare Inc2006-03-29