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FDA 510(k)

PEGASUS BIWAVE PLUS SYSTEM

K-Number: K944310 · 1995-03-17

ApplicantPegasus Airwave, Inc.
Decision Date1995-03-17
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PEGASUS BIWAVE PLUS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pegasus Airwave, Inc.. It received FDA 510(k) clearance on 1995-03-17 under 510(k) number K944310. 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 PEGASUS BIWAVE PLUS SYSTEM?

PEGASUS BIWAVE PLUS SYSTEM is a medical device that received FDA 510(k) clearance on 1995-03-17. The listed applicant is Pegasus Airwave, Inc.. The 510(k) number is K944310.

When did PEGASUS BIWAVE PLUS SYSTEM receive FDA 510(k) clearance?

PEGASUS BIWAVE PLUS SYSTEM received FDA 510(k) clearance on 1995-03-17, under 510(k) number K944310.

Who is the listed applicant for PEGASUS BIWAVE PLUS SYSTEM?

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

What is the FDA product code for PEGASUS BIWAVE PLUS SYSTEM?

The FDA product code for PEGASUS BIWAVE PLUS SYSTEM 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 Pegasus Airwave, 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.

K930742PEGASUS PROACTIVE WHEELCHAIR CUSHIONK933004PEGASUS BIWAVE SYSTEMK874877PEGASUS AIRWAVE SYST/SPEC MATTRESS DECUBITUS ULCER

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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