BILIBLANKET PHOTOTHERAPY DEVICE— 510(k) K894129

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K894129 for BILIBLANKET PHOTOTHERAPY DEVICE, Substantially Equivalent on 1989-09-28. Applicant: Ohmeda Medical. Device class: 2.

Clearance details

Applicant: Ohmeda Medical
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 1989-06-12
Decision date: 1989-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, 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.