FDA 510(k)

LASER PHOTOCOAGULATOR

K-Number: K837306 · 1983-04-21

Decision Date1983-04-21

Product Code

DecisionSubstantially Equivalent

Device Summary

LASER PHOTOCOAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Hgm, Inc.. It received FDA 510(k) clearance on 1983-04-21 under 510(k) number K837306. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASER PHOTOCOAGULATOR?

LASER PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 1983-04-21. The listed applicant is Hgm, Inc.. The 510(k) number is K837306.

When did LASER PHOTOCOAGULATOR receive FDA 510(k) clearance?

LASER PHOTOCOAGULATOR received FDA 510(k) clearance on 1983-04-21, under 510(k) number K837306.

Who is the listed applicant for LASER PHOTOCOAGULATOR?

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

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Other records listing Hgm, Inc. as applicant

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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.