Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SPECTRA 305/350

K-Number: K820280 · 1982-03-05

ApplicantUltralite
Decision Date1982-03-05
Product CodeKGL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPECTRA 305/350 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 K820280. The device is classified under product code KGL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRA 305/350?

SPECTRA 305/350 is a medical device that received FDA 510(k) clearance on 1982-03-05. The listed applicant is Ultralite. The 510(k) number is K820280.

When did SPECTRA 305/350 receive FDA 510(k) clearance?

SPECTRA 305/350 received FDA 510(k) clearance on 1982-03-05, under 510(k) number K820280.

Who is the listed applicant for SPECTRA 305/350?

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 SPECTRA 305/350?

The FDA product code for SPECTRA 305/350 is KGL.

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 SYSTEMK820492SPECTRA305K827123SPECTRA (ULTRAVIOLET PRODUCTS)K761179PSORALITE

Related Devices (Code: KGL)

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.

K852575WALDMANN F85/100W PUVASylvania Lighting ProductsK841795UV 8001K, PUVA 800, PUVA 180/200 1000Waldmann Lighting Co.K810668HO-B-LITE VI UNITNational Biological Corp.K810358PHOTOTHERAPY LIGHT CHAMBERPaul B. Elder Co.K791977PSORALITE MARK IPaul B. Elder Co.K791116PSORALITE SERIES 30,000Paul B. Elder Co.

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.

↑