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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 K921978
Device Name BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE
Applicant
Core-M, Inc.
P.O. Box 1080
129 Braintree St.
Allston,  MA  02134
Applicant Contact NATAN E PARSONS
Correspondent
Core-M, Inc.
P.O. Box 1080
129 Braintree St.
Allston,  MA  02134
Correspondent Contact NATAN E PARSONS
Regulation Number868.2600
Classification Product Code
CAP  
Date Received04/28/1992
Decision Date 11/17/1992
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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