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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K913472
Device Name LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM
Applicant
Baxter Healthcare Corp
2132 Michelson Dr.
Irvine,  CA  92715
Applicant Contact CAROLE E MARCOT
Correspondent
Baxter Healthcare Corp
2132 Michelson Dr.
Irvine,  CA  92715
Correspondent Contact CAROLE E MARCOT
Regulation Number892.1570
Classification Product Code
ITX  
Date Received08/05/1991
Decision Date 03/13/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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