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FDA 510(k)

THERMO-K

K-Number: K820814 · 1982-04-29

ApplicantAmerican Medical Systems, Inc.
Decision Date1982-04-29
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THERMO-K is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems, Inc.. It received FDA 510(k) clearance on 1982-04-29 under 510(k) number K820814. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMO-K?

THERMO-K is a medical device that received FDA 510(k) clearance on 1982-04-29. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K820814.

When did THERMO-K receive FDA 510(k) clearance?

THERMO-K received FDA 510(k) clearance on 1982-04-29, under 510(k) number K820814.

Who is the listed applicant for THERMO-K?

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

What is the FDA product code for THERMO-K?

The FDA product code for THERMO-K is DWJ.

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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.

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