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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 K780863
Device Name MODEL 65 HIGH & LOW PRESSURE ALARM
Applicant
THE JOHN BUNN CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
THE JOHN BUNN CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.2600
Classification Product Code
CAP  
Date Received05/30/1978
Decision Date 08/21/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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