FDA 510(k)

FPL

K-Number: K915897 · 1992-04-07

Decision Date1992-04-07

Product CodeIKE

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

FPL is the device name listed in this FDA 510(k) record. The listed applicant is Wrm Computers. It received FDA 510(k) clearance on 1992-04-07 under 510(k) number K915897. The device is classified under product code IKE. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FPL?

FPL is a medical device that received FDA 510(k) clearance on 1992-04-07. The listed applicant is Wrm Computers. The 510(k) number is K915897.

When did FPL receive FDA 510(k) clearance?

FPL received FDA 510(k) clearance on 1992-04-07, under 510(k) number K915897.

Who is the listed applicant for FPL?

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

What is the FDA product code for FPL?

The FDA product code for FPL is IKE.

Other records listing Wrm Computers 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.

K915278CDG GAIT ANALYSES SYSTEM

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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.