FDA 510(k)

SPECTRA (ULTRAVIOLET PRODUCTS)

K-Number: K827123 · 1982-03-05

Decision Date1982-03-05

Product Code

DecisionSubstantially Equivalent

Device Summary

SPECTRA (ULTRAVIOLET PRODUCTS) is the device name listed in this FDA 510(k) record. The listed applicant is Ultralite. It received FDA 510(k) clearance on 1982-03-05 under 510(k) number K827123. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRA (ULTRAVIOLET PRODUCTS)?

SPECTRA (ULTRAVIOLET PRODUCTS) is a medical device that received FDA 510(k) clearance on 1982-03-05. The listed applicant is Ultralite. The 510(k) number is K827123.

When did SPECTRA (ULTRAVIOLET PRODUCTS) receive FDA 510(k) clearance?

SPECTRA (ULTRAVIOLET PRODUCTS) received FDA 510(k) clearance on 1982-03-05, under 510(k) number K827123.

Who is the listed applicant for SPECTRA (ULTRAVIOLET PRODUCTS)?

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

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ultralite as applicant

K910091ULTRALITE PANELITE K861963ULTRALITE HF1236 HAND AND FOOT SYSTEM K820492SPECTRA305 K820280SPECTRA 305/350 K761179PSORALITE

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.