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FDA 510(k)

INFANT RADIANT WARMER - MODELS IW910 AND IW920

K-Number: K970432 · 1997-05-07

ApplicantFisher & Paykel Electronics , Ltd.
Decision Date1997-05-07
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFANT RADIANT WARMER - MODELS IW910 AND IW920 is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Electronics , Ltd.. It received FDA 510(k) clearance on 1997-05-07 under 510(k) number K970432. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFANT RADIANT WARMER - MODELS IW910 AND IW920?

INFANT RADIANT WARMER - MODELS IW910 AND IW920 is a medical device that received FDA 510(k) clearance on 1997-05-07. The listed applicant is Fisher & Paykel Electronics , Ltd.. The 510(k) number is K970432.

When did INFANT RADIANT WARMER - MODELS IW910 AND IW920 receive FDA 510(k) clearance?

INFANT RADIANT WARMER - MODELS IW910 AND IW920 received FDA 510(k) clearance on 1997-05-07, under 510(k) number K970432.

Who is the listed applicant for INFANT RADIANT WARMER - MODELS IW910 AND IW920?

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

What is the FDA product code for INFANT RADIANT WARMER - MODELS IW910 AND IW920?

The FDA product code for INFANT RADIANT WARMER - MODELS IW910 AND IW920 is FMT.

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Other records listing Fisher & Paykel Electronics , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FMT)

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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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