FDA 510(k)

W.M.E. GPS 1001

K-Number: K961751 · 1997-09-25

ApplicantWeaver Medical Electronics, Inc.

Decision Date1997-09-25

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

W.M.E. GPS 1001 is the device name listed in this FDA 510(k) record. The listed applicant is Weaver Medical Electronics, Inc.. It received FDA 510(k) clearance on 1997-09-25 under 510(k) number K961751. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the W.M.E. GPS 1001?

W.M.E. GPS 1001 is a medical device that received FDA 510(k) clearance on 1997-09-25. The listed applicant is Weaver Medical Electronics, Inc.. The 510(k) number is K961751.

When did W.M.E. GPS 1001 receive FDA 510(k) clearance?

W.M.E. GPS 1001 received FDA 510(k) clearance on 1997-09-25, under 510(k) number K961751.

Who is the listed applicant for W.M.E. GPS 1001?

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

What is the FDA product code for W.M.E. GPS 1001?

The FDA product code for W.M.E. GPS 1001 is IPF.

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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.