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FDA 510(k)

PARAGON PORTABLE

K-Number: K945041 · 1995-03-16

ApplicantPegabus Egerton, Ltd.
Decision Date1995-03-16
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PARAGON PORTABLE is the device name listed in this FDA 510(k) record. The listed applicant is Pegabus Egerton, Ltd.. It received FDA 510(k) clearance on 1995-03-16 under 510(k) number K945041. 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 PARAGON PORTABLE?

PARAGON PORTABLE is a medical device that received FDA 510(k) clearance on 1995-03-16. The listed applicant is Pegabus Egerton, Ltd.. The 510(k) number is K945041.

When did PARAGON PORTABLE receive FDA 510(k) clearance?

PARAGON PORTABLE received FDA 510(k) clearance on 1995-03-16, under 510(k) number K945041.

Who is the listed applicant for PARAGON PORTABLE?

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

What is the FDA product code for PARAGON PORTABLE?

The FDA product code for PARAGON PORTABLE is FNM.

Related Clinical Trials

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Other records listing Pegabus Egerton, 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.

K945042ELITE 3 LOW AIR LOSS BED

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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