BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE— 510(k) K921978

Name: FDA 510(k) clearance K921978
Creator: U.S. Food and Drug Administration
Published: 1992-11-17

Substantially Equivalent

Core-M, Inc.

FDA 510(k) clearance K921978 for BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE, Substantially Equivalent on 1992-11-17. Applicant: Core-M, Inc.. Device class: 2.

Clearance details

Applicant: Core-M, Inc.
Product code: Code CAP
Device class: Class 2
Regulation: 21 CFR 868.2600
Advisory panel: Anesthesiology
Date received: 1992-04-28
Decision date: 1992-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allston, MA, US

Download summary PDF View on FDA.gov ↗

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