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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K910049
Device Name INTERSPEC APOGEE, MODIFICATION
Applicant
Interspec, Inc.
110 W. Butler Ave.
Ambler,  PA  19002
Applicant Contact ARTHUR J SCHENCK
Correspondent
Interspec, Inc.
110 W. Butler Ave.
Ambler,  PA  19002
Correspondent Contact ARTHUR J SCHENCK
Regulation Number870.2100
Classification Product Code
DPW  
Date Received01/07/1991
Decision Date 04/29/1991
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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