CO BREATH ANALYSIS MODULE & MONOXOL II— 510(k) K952694

Name: FDA 510(k) clearance K952694
Creator: U.S. Food and Drug Administration
Published: 1996-01-29

Substantially Equivalent

Bacharach, Inc.

FDA 510(k) clearance K952694 for CO BREATH ANALYSIS MODULE & MONOXOL II, Substantially Equivalent on 1996-01-29. Applicant: Bacharach, Inc.. Device class: 2.

Clearance details

Applicant: Bacharach, Inc.
Product code: Code CCJ
Device class: Class 2
Regulation: 21 CFR 868.1430
Advisory panel: Anesthesiology
Date received: 1995-06-14
Decision date: 1996-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, US

Download summary PDF View on FDA.gov ↗

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