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FDA 510(k)

EUROTAN BY AYK

K-Number: K860489 · 1986-02-24

ApplicantEurotan Intl.
Decision Date1986-02-24
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

EUROTAN BY AYK is the device name listed in this FDA 510(k) record. The listed applicant is Eurotan Intl.. It received FDA 510(k) clearance on 1986-02-24 under 510(k) number K860489. 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 EUROTAN BY AYK?

EUROTAN BY AYK is a medical device that received FDA 510(k) clearance on 1986-02-24. The listed applicant is Eurotan Intl.. The 510(k) number is K860489.

When did EUROTAN BY AYK receive FDA 510(k) clearance?

EUROTAN BY AYK received FDA 510(k) clearance on 1986-02-24, under 510(k) number K860489.

Who is the listed applicant for EUROTAN BY AYK?

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

What is the FDA product code for EUROTAN BY AYK?

The FDA product code for EUROTAN BY AYK is FTC.

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Other records listing Eurotan Intl. 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.

K853911UV-A SUNTANNING EQUIPMENTK840555WALDMANN SUNTANNING EQUIP-MODELS'SK820827P105

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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