FDA 510(k)

UVATEC SUNTAMED 400

K-Number: K828670 · 1983-01-17

Decision Date1983-01-17

Product Code

DecisionSubstantially Equivalent

Device Summary

UVATEC SUNTAMED 400 is the device name listed in this FDA 510(k) record. The listed applicant is Solitec GmbH. It received FDA 510(k) clearance on 1983-01-17 under 510(k) number K828670. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UVATEC SUNTAMED 400?

UVATEC SUNTAMED 400 is a medical device that received FDA 510(k) clearance on 1983-01-17. The listed applicant is Solitec GmbH. The 510(k) number is K828670.

When did UVATEC SUNTAMED 400 receive FDA 510(k) clearance?

UVATEC SUNTAMED 400 received FDA 510(k) clearance on 1983-01-17, under 510(k) number K828670.

Who is the listed applicant for UVATEC SUNTAMED 400?

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Solitec GmbH as applicant

K903660DERMALIGHT PSORACOMB K828671UVATEC SUNTAMED 4000 AND 2000

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.