FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TX-2 THERMAL DILUTION CARDIAC OUTPUT
K Number: K834408
·
Decision Aug 23, 1984
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
176
Applicant Total
12
Review Days
253
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TX-2 THERMAL DILUTION CARDIAC OUTPUT
- K Number
- K834408
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1435
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Waters Instruments, Inc.
- Date Received
- December 14, 1983
- Decision Date
- August 23, 1984
- Product Code
- DXG
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXG), ordered by most recent decision date.
Argos Infinity (Rev. 1.0)
FDA 510(k)
FDA Class 2
·Cardiovascular
VitalStream ART Connect; VitalStream-Hemo
FDA 510(k)
FDA Class 2
·Cardiovascular
Cogent Hemodynamic Monitoring System; Cogent HMS
FDA 510(k)
FDA Class 2
·Cardiovascular
Hypotension Decision Assist Model HDA-OR2
FDA 510(k)
FDA Class 2
·Cardiovascular
PulsioFlex Monitoring System with ProAQT Sensor
FDA 510(k)
FDA Class 2
·Cardiovascular
EV1000 Clinical Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Waters Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K053169 | RM3 RENAL PRESERVATION SYSTEM | Jan 17, 2006 | Substantially Equivalent |
| K042224 | RM3 RENAL PRESERVATION SYSTEM | Oct 22, 2004 | Substantially Equivalent |
| K971571 | RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT | Jul 29, 1997 | Substantially Equivalent |
| K921519 | OXICOM-2100 | Oct 23, 1992 | Substantially Equivalent |
| K911207 | OXICOMPLUS | Aug 26, 1991 | Substantially Equivalent |
| K863210 | VELCOM-100 | Nov 26, 1986 | Substantially Equivalent |
| K862161 | OSC-80 OXIMETER | Aug 18, 1986 | Substantially Equivalent |
| K852909 | MVP - 6000 | Nov 14, 1985 | Substantially Equivalent |
| K841876 | POLYURETHANE THERMAL DILUTION CATHET | Jul 13, 1984 | Substantially Equivalent |
| K813585 | WATERS ILEOSTOMY VALVE | Apr 9, 1982 | Substantially Equivalent |