SURGICAL PATIENT WARMER, MODEL PW820 JHU

Lamp, Infrared, Therapeutic Heating

FISHER & PAYKEL HEALTHCARE, LTD.

The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Surgical Patient Warmer, Model Pw820 Jhu.

Pre-market Notification Details

Device IDK022609
510k NumberK022609
Device Name:SURGICAL PATIENT WARMER, MODEL PW820 JHU
ClassificationLamp, Infrared, Therapeutic Heating
Applicant FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki,  NZ
ContactRobert Petry
CorrespondentRobert Petry
FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki,  NZ
Product CodeILY  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-08-06
Decision Date2003-03-06
Summary:summary

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