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FDA 510(k)

MODIFIED PEDIKAIR

K-Number: K954320 · 1997-07-18

ApplicantKinetic Concepts, Inc.
Decision Date1997-07-18
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFIED PEDIKAIR is the device name listed in this FDA 510(k) record. The listed applicant is Kinetic Concepts, Inc.. It received FDA 510(k) clearance on 1997-07-18 under 510(k) number K954320. 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 MODIFIED PEDIKAIR?

MODIFIED PEDIKAIR is a medical device that received FDA 510(k) clearance on 1997-07-18. The listed applicant is Kinetic Concepts, Inc.. The 510(k) number is K954320.

When did MODIFIED PEDIKAIR receive FDA 510(k) clearance?

MODIFIED PEDIKAIR received FDA 510(k) clearance on 1997-07-18, under 510(k) number K954320.

Who is the listed applicant for MODIFIED PEDIKAIR?

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

What is the FDA product code for MODIFIED PEDIKAIR?

The FDA product code for MODIFIED PEDIKAIR is FNM.

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Other records listing Kinetic Concepts, Inc. as applicant

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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

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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