FDA 510(k)

BIO-STIMULATOR, MODEL 400

K-Number: K813100 · 1981-11-27

Decision Date1981-11-27

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

BIO-STIMULATOR, MODEL 400 is the device name listed in this FDA 510(k) record. The listed applicant is Med-Western Electronics, Inc.. It received FDA 510(k) clearance on 1981-11-27 under 510(k) number K813100. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-STIMULATOR, MODEL 400?

BIO-STIMULATOR, MODEL 400 is a medical device that received FDA 510(k) clearance on 1981-11-27. The listed applicant is Med-Western Electronics, Inc.. The 510(k) number is K813100.

When did BIO-STIMULATOR, MODEL 400 receive FDA 510(k) clearance?

BIO-STIMULATOR, MODEL 400 received FDA 510(k) clearance on 1981-11-27, under 510(k) number K813100.

Who is the listed applicant for BIO-STIMULATOR, MODEL 400?

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

What is the FDA product code for BIO-STIMULATOR, MODEL 400?

The FDA product code for BIO-STIMULATOR, MODEL 400 is GZJ.

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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.