FDA 510(k)

MD-1A GALVANIC UNIT

K-Number: K964208 · 1997-04-30

Decision Date1997-04-30

Product CodeEGJ

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

MD-1A GALVANIC UNIT is the device name listed in this FDA 510(k) record. The listed applicant is R. A. Fischer Co. Corp.. It received FDA 510(k) clearance on 1997-04-30 under 510(k) number K964208. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MD-1A GALVANIC UNIT?

MD-1A GALVANIC UNIT is a medical device that received FDA 510(k) clearance on 1997-04-30. The listed applicant is R. A. Fischer Co. Corp.. The 510(k) number is K964208.

When did MD-1A GALVANIC UNIT receive FDA 510(k) clearance?

MD-1A GALVANIC UNIT received FDA 510(k) clearance on 1997-04-30, under 510(k) number K964208.

Who is the listed applicant for MD-1A GALVANIC UNIT?

The FDA 510(k) record lists R. A. Fischer Co. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MD-1A GALVANIC UNIT?

The FDA product code for MD-1A GALVANIC UNIT is EGJ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.