TX-2 Thermal Dilution Cardiac Output
FDA 510(k) K834408 · Waters Instruments, Inc.
510(k) numberK834408
Submission
- Device name
- TX-2 Thermal Dilution Cardiac Output
- Applicant
- Waters Instruments, Inc.
Walker, MI, US - Received
- December 14, 1983
- Decision date
- August 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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| K921519 | OXICOM-2100DQA · Traditional | 10/23/1992SE |
| K911207 | OxicomplusDQA · Traditional | 08/26/1991SE |
| K863210 | VELCOM-100DPW · Traditional | 11/26/1986SE |
| K862161 | OSC-80 OximeterDQA · Traditional | 08/18/1986SE |
| K852909 | MVP - 6000BZC · Traditional | 11/14/1985SE |
| K841876 | Polyurethane Thermal Dilution CathetDYG · Traditional | 07/13/1984SE |
| K813585 | Waters Ileostomy ValveKNT · Traditional | 04/09/1982SE |
Questions and answers
When was TX-2 Thermal Dilution Cardiac Output cleared by the FDA?
TX-2 Thermal Dilution Cardiac Output (K834408) received a 510(k) decision of Substantially Equivalent on August 23, 1984, 253 days after the submission was received.
What is the product code of K834408?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.