FDA 510(k)

TRNS MI 8202

K-Number: K840821 · 1984-04-05

Decision Date1984-04-05

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TRNS MI 8202 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Scientific Instruments. It received FDA 510(k) clearance on 1984-04-05 under 510(k) number K840821. 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 TRNS MI 8202?

TRNS MI 8202 is a medical device that received FDA 510(k) clearance on 1984-04-05. The listed applicant is Medical Scientific Instruments. The 510(k) number is K840821.

When did TRNS MI 8202 receive FDA 510(k) clearance?

TRNS MI 8202 received FDA 510(k) clearance on 1984-04-05, under 510(k) number K840821.

Who is the listed applicant for TRNS MI 8202?

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

What is the FDA product code for TRNS MI 8202?

The FDA product code for TRNS MI 8202 is GZJ.

Other records listing Medical Scientific Instruments 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.

K820496TENS MODEL 8201

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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.