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)

UV 8001K, PUVA 800, PUVA 180/200 1000

K-Number: K841795 · 1984-08-30

ApplicantWaldmann Lighting Co.
Decision Date1984-08-30
Product CodeKGL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UV 8001K, PUVA 800, PUVA 180/200 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Waldmann Lighting Co.. It received FDA 510(k) clearance on 1984-08-30 under 510(k) number K841795. 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 UV 8001K, PUVA 800, PUVA 180/200 1000?

UV 8001K, PUVA 800, PUVA 180/200 1000 is a medical device that received FDA 510(k) clearance on 1984-08-30. The listed applicant is Waldmann Lighting Co.. The 510(k) number is K841795.

When did UV 8001K, PUVA 800, PUVA 180/200 1000 receive FDA 510(k) clearance?

UV 8001K, PUVA 800, PUVA 180/200 1000 received FDA 510(k) clearance on 1984-08-30, under 510(k) number K841795.

Who is the listed applicant for UV 8001K, PUVA 800, PUVA 180/200 1000?

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

What is the FDA product code for UV 8001K, PUVA 800, PUVA 180/200 1000?

The FDA product code for UV 8001K, PUVA 800, PUVA 180/200 1000 is KGL.

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 ProductsK820280SPECTRA 305/350UltraliteK810668HO-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.

↑