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FDA 510(k)

SKIN GALVANOMETER

K-Number: K823194 · 1983-01-21

ApplicantSpelson Research Laboratories, Inc.
Decision Date1983-01-21
Product CodeHCJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SKIN GALVANOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Spelson Research Laboratories, Inc.. It received FDA 510(k) clearance on 1983-01-21 under 510(k) number K823194. The device is classified under product code HCJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKIN GALVANOMETER?

SKIN GALVANOMETER is a medical device that received FDA 510(k) clearance on 1983-01-21. The listed applicant is Spelson Research Laboratories, Inc.. The 510(k) number is K823194.

When did SKIN GALVANOMETER receive FDA 510(k) clearance?

SKIN GALVANOMETER received FDA 510(k) clearance on 1983-01-21, under 510(k) number K823194.

Who is the listed applicant for SKIN GALVANOMETER?

The FDA 510(k) record lists Spelson Research Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKIN GALVANOMETER?

The FDA product code for SKIN GALVANOMETER is HCJ.

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Related Devices (Code: HCJ)

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.

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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.

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