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FDA 510(k)

OSRAM ULTRAMED 400 W

K-Number: K863937 · 1986-11-04

ApplicantOsram GmbH
Decision Date1986-11-04
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

OSRAM ULTRAMED 400 W is the device name listed in this FDA 510(k) record. The listed applicant is Osram GmbH. It received FDA 510(k) clearance on 1986-11-04 under 510(k) number K863937. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OSRAM ULTRAMED 400 W?

OSRAM ULTRAMED 400 W is a medical device that received FDA 510(k) clearance on 1986-11-04. The listed applicant is Osram GmbH. The 510(k) number is K863937.

When did OSRAM ULTRAMED 400 W receive FDA 510(k) clearance?

OSRAM ULTRAMED 400 W received FDA 510(k) clearance on 1986-11-04, under 510(k) number K863937.

Who is the listed applicant for OSRAM ULTRAMED 400 W?

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

What is the FDA product code for OSRAM ULTRAMED 400 W?

The FDA product code for OSRAM ULTRAMED 400 W is FTC.

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 Osram GmbH as applicant

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.

K812853OSRAM UVA LAMP

Related Devices (Code: FTC)

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.

K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLCK250425Ultraviolet Phototherapy DeviceAPK Technology Co., Ltd.K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)Boston Aesthetics, Inc.K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)Xuzhou Kernel Medical Equipment Co., Ltd.K242908UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)Shanghai Sigma High-Tech Co., Ltd.

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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