INFANT PHOTOTHERAPY MASK— 510(k) K813214

Name: FDA 510(k) clearance K813214
Creator: U.S. Food and Drug Administration
Published: 1981-12-09

Substantially Equivalent

Montrose Phototherapy Supply

FDA 510(k) clearance K813214 for INFANT PHOTOTHERAPY MASK, Substantially Equivalent on 1981-12-09. Applicant: Montrose Phototherapy Supply. Device class: 1.

Clearance details

Applicant: Montrose Phototherapy Supply
Product code: Code FOK
Device class: Class 1
Regulation: 21 CFR 880.5270
Advisory panel: General Hospital
Date received: 1981-11-09
Decision date: 1981-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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