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FDA 510(k)

MIAMI-SUNNY

K-Number: K861636 · 1986-05-16

ApplicantSunworld Corp.
Decision Date1986-05-16
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MIAMI-SUNNY is the device name listed in this FDA 510(k) record. The listed applicant is Sunworld Corp.. It received FDA 510(k) clearance on 1986-05-16 under 510(k) number K861636. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIAMI-SUNNY?

MIAMI-SUNNY is a medical device that received FDA 510(k) clearance on 1986-05-16. The listed applicant is Sunworld Corp.. The 510(k) number is K861636.

When did MIAMI-SUNNY receive FDA 510(k) clearance?

MIAMI-SUNNY received FDA 510(k) clearance on 1986-05-16, under 510(k) number K861636.

Who is the listed applicant for MIAMI-SUNNY?

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

What is the FDA product code for MIAMI-SUNNY?

The FDA product code for MIAMI-SUNNY 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 Sunworld Corp. 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.

K841614SUN BEDS

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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