FDA 510(k)

UVATEC SUNTAMED 4000 AND 2000

K-Number: K828671 · 1983-01-19

Decision Date1983-01-19

Product Code

DecisionSubstantially Equivalent

Device Summary

UVATEC SUNTAMED 4000 AND 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Solitec GmbH. It received FDA 510(k) clearance on 1983-01-19 under 510(k) number K828671. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UVATEC SUNTAMED 4000 AND 2000?

UVATEC SUNTAMED 4000 AND 2000 is a medical device that received FDA 510(k) clearance on 1983-01-19. The listed applicant is Solitec GmbH. The 510(k) number is K828671.

When did UVATEC SUNTAMED 4000 AND 2000 receive FDA 510(k) clearance?

UVATEC SUNTAMED 4000 AND 2000 received FDA 510(k) clearance on 1983-01-19, under 510(k) number K828671.

Who is the listed applicant for UVATEC SUNTAMED 4000 AND 2000?

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

Related Clinical Trials

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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Other records listing Solitec GmbH as applicant

K903660DERMALIGHT PSORACOMB K828670UVATEC SUNTAMED 400

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.