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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 K861720
Device Name MODIFIED BAROMED BREATHING PRESSURE MONITOR
Applicant
DRAEGER MEDICAL, INC.
148 B. QUARRY RD.
TELFORD,  PA  18969
Applicant Contact EDWARD T GRIFFITH
Correspondent
DRAEGER MEDICAL, INC.
148 B. QUARRY RD.
TELFORD,  PA  18969
Correspondent Contact EDWARD T GRIFFITH
Regulation Number868.2600
Classification Product Code
CAP  
Date Received05/05/1986
Decision Date 05/09/1986
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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