FDA 510(k)

P/2000

K-Number: K944411 · 1994-12-27

Decision Date1994-12-27

Product CodeFNM

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

P/2000 is the device name listed in this FDA 510(k) record. The listed applicant is Plexus Medical. It received FDA 510(k) clearance on 1994-12-27 under 510(k) number K944411. 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 P/2000?

P/2000 is a medical device that received FDA 510(k) clearance on 1994-12-27. The listed applicant is Plexus Medical. The 510(k) number is K944411.

When did P/2000 receive FDA 510(k) clearance?

P/2000 received FDA 510(k) clearance on 1994-12-27, under 510(k) number K944411.

Who is the listed applicant for P/2000?

The FDA 510(k) record lists Plexus Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for P/2000?

The FDA product code for P/2000 is FNM.

Other records listing Plexus Medical 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.

K952610PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500)K943353PLEXUS/1000

Related Devices (Code: FNM)

K973169PRESSURE GUARD SITE SELECT (A)Span-America Medical Systems, Inc.K972022ZAK-2000Cardio Systems, Inc.K974319MIGHTY AIRWheelchairs of Kansas K974070PHYSIO/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.