TX-2 THERMAL DILUTION CARDIAC OUTPUT

Computer, Diagnostic, Pre-programmed, Single-function

WATERS INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Waters Instruments, Inc. with the FDA for Tx-2 Thermal Dilution Cardiac Output.

Pre-market Notification Details

• Device ID: K834408
• 510k Number: K834408
• Device Name: TX-2 THERMAL DILUTION CARDIAC OUTPUT
• Classification: Computer, Diagnostic, Pre-programmed, Single-function
• Applicant: WATERS INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: DXG
• CFR Regulation Number: 870.1435 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-12-14
• Decision Date: 1984-08-23