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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 K943146
Device Name PORTA-RESP MONITOR
Applicant
S & M Instrument Co.
202 Airport Blvd.
Doylestown,  PA  18901
Applicant Contact MARY LETVENKO
Correspondent
S & M Instrument Co.
202 Airport Blvd.
Doylestown,  PA  18901
Correspondent Contact MARY LETVENKO
Regulation Number868.2600
Classification Product Code
CAP  
Date Received06/30/1994
Decision Date 11/28/1994
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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