BILIBLANKET PLUS PHOTOTHERAPY SYSTEM— 510(k) K934946

Name: FDA 510(k) clearance K934946
Creator: U.S. Food and Drug Administration
Published: 1994-07-05

Substantially Equivalent

Boc Health Care, Inc.

FDA 510(k) clearance K934946 for BILIBLANKET PLUS PHOTOTHERAPY SYSTEM, Substantially Equivalent on 1994-07-05. Applicant: Boc Health Care, Inc.. Device class: 2.

Clearance details

Applicant: Boc Health Care, Inc.
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 1993-10-18
Decision date: 1994-07-05
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.