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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K834408
Device Name TX-2 THERMAL DILUTION CARDIAC OUTPUT
Applicant
Waters Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Waters Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1435
Classification Product Code
DXG  
Date Received12/14/1983
Decision Date 08/23/1984
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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