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FDA 510(k)

FOLDALITE UNIT

K-Number: K827890 · 1982-08-23

ApplicantNational Biological Corp.
Decision Date1982-08-23
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FOLDALITE UNIT is the device name listed in this FDA 510(k) record. The listed applicant is National Biological Corp.. It received FDA 510(k) clearance on 1982-08-23 under 510(k) number K827890. 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 FOLDALITE UNIT?

FOLDALITE UNIT is a medical device that received FDA 510(k) clearance on 1982-08-23. The listed applicant is National Biological Corp.. The 510(k) number is K827890.

When did FOLDALITE UNIT receive FDA 510(k) clearance?

FOLDALITE UNIT received FDA 510(k) clearance on 1982-08-23, under 510(k) number K827890.

Who is the listed applicant for FOLDALITE UNIT?

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

What is the FDA product code for FOLDALITE UNIT?

The FDA product code for FOLDALITE UNIT is FTC.

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Other records listing National Biological Corp. as applicant

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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