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FDA 510(k)

SPECTRA305

K-Number: K820492 · 1982-03-31

ApplicantUltralite
Decision Date1982-03-31
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPECTRA305 is the device name listed in this FDA 510(k) record. The listed applicant is Ultralite. It received FDA 510(k) clearance on 1982-03-31 under 510(k) number K820492. 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 SPECTRA305?

SPECTRA305 is a medical device that received FDA 510(k) clearance on 1982-03-31. The listed applicant is Ultralite. The 510(k) number is K820492.

When did SPECTRA305 receive FDA 510(k) clearance?

SPECTRA305 received FDA 510(k) clearance on 1982-03-31, under 510(k) number K820492.

Who is the listed applicant for SPECTRA305?

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

What is the FDA product code for SPECTRA305?

The FDA product code for SPECTRA305 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ultralite 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.

K910091ULTRALITE PANELITEK861963ULTRALITE HF1236 HAND AND FOOT SYSTEMK820280SPECTRA 305/350K827123SPECTRA (ULTRAVIOLET PRODUCTS)K761179PSORALITE

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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