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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K874326
Device Name SYSTEM VI MONITOR
Applicant
Air-Shields, Inc.
330 Jacksonville Rd.
Hatboro,  PA  19040
Applicant Contact FRANCIS X CASEY
Correspondent
Air-Shields, Inc.
330 Jacksonville Rd.
Hatboro,  PA  19040
Correspondent Contact FRANCIS X CASEY
Regulation Number870.2340
Classification Product Code
DPS  
Date Received10/21/1987
Decision Date 12/05/1988
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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