OMNI INFANT PHOTOTHERAPY UNIT— 510(k) K834430

Name: FDA 510(k) clearance K834430
Creator: U.S. Food and Drug Administration
Published: 1984-04-30

Substantially Equivalent

Rocky Mountain Medical Corp.

FDA 510(k) clearance K834430 for OMNI INFANT PHOTOTHERAPY UNIT, Substantially Equivalent on 1984-04-30. Applicant: Rocky Mountain Medical Corp.. Device class: 2.

Clearance details

Applicant: Rocky Mountain Medical Corp.
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 1983-12-16
Decision date: 1984-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.