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FDA 510(k)

LIFE ISLAND 21

K-Number: K925651 · 1993-07-27

ApplicantKeisei (Usa) Co., Ltd.
Decision Date1993-07-27
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LIFE ISLAND 21 is the device name listed in this FDA 510(k) record. The listed applicant is Keisei (Usa) Co., Ltd.. It received FDA 510(k) clearance on 1993-07-27 under 510(k) number K925651. The device is classified under product code FNM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFE ISLAND 21?

LIFE ISLAND 21 is a medical device that received FDA 510(k) clearance on 1993-07-27. The listed applicant is Keisei (Usa) Co., Ltd.. The 510(k) number is K925651.

When did LIFE ISLAND 21 receive FDA 510(k) clearance?

LIFE ISLAND 21 received FDA 510(k) clearance on 1993-07-27, under 510(k) number K925651.

Who is the listed applicant for LIFE ISLAND 21?

The FDA 510(k) record lists Keisei (Usa) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFE ISLAND 21?

The FDA product code for LIFE ISLAND 21 is FNM.

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 Keisei (Usa) Co., 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.

K950613KEISEI

Related Devices (Code: FNM)

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.

K973169PRESSURE GUARD SITE SELECT (A)Span-America Medical Systems, Inc.K972022ZAK-2000Cardio Systems, Inc.K974319MIGHTY AIRWheelchairs of KansasK974070PHYSIO/1000Physio Designs, Inc.K972549SIMPULSEKinetic Concepts, Inc.K970081SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEMCathay Consolidated, Inc.

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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