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FDA 510(k)

INFANT LIFE SUPPORT MODULE-20

K-Number: K854065 · 1986-01-16

ApplicantIntl. Biomedics, Inc.
Decision Date1986-01-16
Product CodeFPL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFANT LIFE SUPPORT MODULE-20 is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Biomedics, Inc.. It received FDA 510(k) clearance on 1986-01-16 under 510(k) number K854065. 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 INFANT LIFE SUPPORT MODULE-20?

INFANT LIFE SUPPORT MODULE-20 is a medical device that received FDA 510(k) clearance on 1986-01-16. The listed applicant is Intl. Biomedics, Inc.. The 510(k) number is K854065.

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

INFANT LIFE SUPPORT MODULE-20 received FDA 510(k) clearance on 1986-01-16, under 510(k) number K854065.

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

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

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

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

Related Clinical Trials

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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Other records listing Intl. 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.

K882551AMBULATORY PH DATA RECORDER SYSTEM, APH-2000

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 CorporationK103525A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOXInternational Biomedical, Ltd.K103523185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR 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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