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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
510(k) Number K892942
Device Name BREATH TRACKER
Applicant
Core-M, Inc.
325 Harvard St.
Brookline,  MA 
Applicant Contact NATAN PARSONS
Correspondent
Core-M, Inc.
325 Harvard St.
Brookline,  MA 
Correspondent Contact NATAN PARSONS
Regulation Number868.2600
Classification Product Code
CAP  
Date Received04/21/1989
Decision Date 06/23/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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