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FDA 510(k)

SURGICAL PATIENT WARMER, MODEL PW820 JHU

K-Number: K022609 · 2003-03-06

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2003-03-06
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SURGICAL PATIENT WARMER, MODEL PW820 JHU is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2003-03-06 under 510(k) number K022609. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL PATIENT WARMER, MODEL PW820 JHU?

SURGICAL PATIENT WARMER, MODEL PW820 JHU is a medical device that received FDA 510(k) clearance on 2003-03-06. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K022609.

When did SURGICAL PATIENT WARMER, MODEL PW820 JHU receive FDA 510(k) clearance?

SURGICAL PATIENT WARMER, MODEL PW820 JHU received FDA 510(k) clearance on 2003-03-06, under 510(k) number K022609.

Who is the listed applicant for SURGICAL PATIENT WARMER, MODEL PW820 JHU?

The FDA 510(k) record lists Fisher & Paykel Healthcare, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL PATIENT WARMER, MODEL PW820 JHU?

The FDA product code for SURGICAL PATIENT WARMER, MODEL PW820 JHU is ILY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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