BREATH TRACKER— 510(k) K892942

Substantially Equivalent

Core-M, Inc.

FDA 510(k) clearance K892942 for BREATH TRACKER, Substantially Equivalent on 1989-06-23. 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: 1989-04-21
Decision date: 1989-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brookline, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Core-M, Inc.

K960861 — OMICRON MONITOR, DELTA MONITOR1996-08-19
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Data sourced from openFDA. This site is unofficial and independent of the FDA.