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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K790036
Device Name DIGITAL BPM
Applicant
Narco Air-Shields
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Narco Air-Shields
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.2870
Classification Product Code
DXO  
Date Received01/08/1979
Decision Date 03/02/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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