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FDA 510(k)

MODIFICATION TO TRANSPORT INCUBATOR 185

K-Number: K031096 · 2003-06-24

ApplicantInternational Biomedics, Inc.
Decision Date2003-06-24
Product CodeFPL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO TRANSPORT INCUBATOR 185 is the device name listed in this FDA 510(k) record. The listed applicant is International Biomedics, Inc.. It received FDA 510(k) clearance on 2003-06-24 under 510(k) number K031096. 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 TRANSPORT INCUBATOR 185?

MODIFICATION TO TRANSPORT INCUBATOR 185 is a medical device that received FDA 510(k) clearance on 2003-06-24. The listed applicant is International Biomedics, Inc.. The 510(k) number is K031096.

When did MODIFICATION TO TRANSPORT INCUBATOR 185 receive FDA 510(k) clearance?

MODIFICATION TO TRANSPORT INCUBATOR 185 received FDA 510(k) clearance on 2003-06-24, under 510(k) number K031096.

Who is the listed applicant for MODIFICATION TO TRANSPORT INCUBATOR 185?

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

What is the FDA product code for MODIFICATION TO TRANSPORT INCUBATOR 185?

The FDA product code for MODIFICATION TO TRANSPORT INCUBATOR 185 is FPL.

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Other records listing International Biomedics, Inc. 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.

K862072FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01K860933AIR-CUSHION TOCOTONOMETERK860295FETASCAN 1500K852439FETA SCAN 1000 OBSTETRICAL IMAGER

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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