BABYTHERM 8000 WB— 510(k) K945467

Substantially Equivalent

Drager, Inc.

FDA 510(k) clearance K945467 for BABYTHERM 8000 WB, Substantially Equivalent on 1995-04-28. Applicant: Drager, Inc.. Device class: 2.

Clearance details

Applicant: Drager, Inc.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1994-11-07
Decision date: 1995-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chantilly, VA, 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.