510(k) K761166
K761166 is an FDA 510(k) premarket notification submitted by Waters Assoc., Inc. for the device "TC-1 CARDIAC OUTPUT COMPUTER". The FDA issued a decision of Substantially Equivalent on December 9, 1976. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Waters Assoc., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1976
- Date Received
- December 1, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Pre-Programmed, Single-Function
- Device Class
- Class II
- Regulation Number
- 870.1435
- Review Panel
- CV
- Submission Type