NEONATAL PHOTOTHERAPY UNIT— 510(k) K802702

Name: FDA 510(k) clearance K802702
Creator: U.S. Food and Drug Administration
Published: 1980-12-10

Substantially Equivalent

Ohio Medical Products

FDA 510(k) clearance K802702 for NEONATAL PHOTOTHERAPY UNIT, Substantially Equivalent on 1980-12-10. Applicant: Ohio Medical Products. Device class: 2.

Clearance details

Applicant: Ohio Medical Products
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 1980-11-03
Decision date: 1980-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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