BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER— 510(k) K943797

Name: FDA 510(k) clearance K943797
Creator: U.S. Food and Drug Administration
Published: 1995-05-11

Substantially Equivalent

Bpr Medical, Ltd.

FDA 510(k) clearance K943797 for BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER, Substantially Equivalent on 1995-05-11. Applicant: Bpr Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Bpr Medical, Ltd.
Product code: Code BZR
Device class: Class 2
Regulation: 21 CFR 868.5330
Advisory panel: Anesthesiology
Date received: 1994-08-03
Decision date: 1995-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, Notts. England, GB

Download summary PDF View on FDA.gov ↗

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