HEMOLASER HEMOSCOPE— 510(k) K893816

Substantially Equivalent

Hemolaser Corp.

FDA 510(k) clearance K893816 for HEMOLASER HEMOSCOPE, Substantially Equivalent on 1990-02-01. Applicant: Hemolaser Corp.. Device class: 2.

Clearance details

Applicant: Hemolaser Corp.
Product code: Code LYK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1989-05-23
Decision date: 1990-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.