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FDA 510(k)

MODIFICATION TO INFANT LIFE SUPPORT MODULE-20

K-Number: K022876 · 2002-09-11

ApplicantInternational Biomedical, Inc.
Decision Date2002-09-11
Product CodeFPL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 is the device name listed in this FDA 510(k) record. The listed applicant is International Biomedical, Inc.. It received FDA 510(k) clearance on 2002-09-11 under 510(k) number K022876. The device is classified under product code FPL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO INFANT LIFE SUPPORT MODULE-20?

MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 is a medical device that received FDA 510(k) clearance on 2002-09-11. The listed applicant is International Biomedical, Inc.. The 510(k) number is K022876.

When did MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 receive FDA 510(k) clearance?

MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 received FDA 510(k) clearance on 2002-09-11, under 510(k) number K022876.

Who is the listed applicant for MODIFICATION TO INFANT LIFE SUPPORT MODULE-20?

The FDA 510(k) record lists International Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO INFANT LIFE SUPPORT MODULE-20?

The FDA product code for MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 is FPL.

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Other records listing International Biomedical, Inc. as applicant

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Related Devices (Code: FPL)

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.

K220742NxtGen Infant Transport IncubatorInternational BiomedicalK161918SREE MRI Transport IncubatorAdvanced Imaging Research Dba Sree Medical SystemsK123937ATOM TRANSCAPSULE V-707Atom Medical CorporationK103523185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOXInternational Biomedical, Ltd.K103525A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOXInternational Biomedical, Ltd.K103524VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOXInternational Biomedical, Ltd.

Official Source

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

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