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FDA 510(k)

SPECTRA 724

K-Number: K854498 · 1985-11-25

ApplicantDaavlin Co.
Decision Date1985-11-25
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPECTRA 724 is the device name listed in this FDA 510(k) record. The listed applicant is Daavlin Co.. It received FDA 510(k) clearance on 1985-11-25 under 510(k) number K854498. 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 SPECTRA 724?

SPECTRA 724 is a medical device that received FDA 510(k) clearance on 1985-11-25. The listed applicant is Daavlin Co.. The 510(k) number is K854498.

When did SPECTRA 724 receive FDA 510(k) clearance?

SPECTRA 724 received FDA 510(k) clearance on 1985-11-25, under 510(k) number K854498.

Who is the listed applicant for SPECTRA 724?

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

What is the FDA product code for SPECTRA 724?

The FDA product code for SPECTRA 724 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 Daavlin Co. 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.

K0636213 SERIES PHOTOTHERAPY CABINETK930856PSORALITEK828654UVB CABINET OR GOEKERMAN CABINET, MODEL SPECTRA 305K827690SPECTRA MINI, ULTRAVIOLET EMITTER FOR DERMATOLOGICAL USE

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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