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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K981720
Device Name IQ SYSTEM
Applicant
Renaissance Technology, Inc.
170 Pheasant Run
Newtown,  PA  18940
Applicant Contact PHILIP E HAMSKI
Correspondent
Renaissance Technology, Inc.
170 Pheasant Run
Newtown,  PA  18940
Correspondent Contact PHILIP E HAMSKI
Regulation Number870.2770
Classification Product Code
DSB  
Date Received05/05/1998
Decision Date 02/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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