The following data is part of a premarket notification filed by Transonic Systems, Inc. with the FDA for Transonic Costatus Cardiac Output System.
| Device ID | K113821 |
| 510k Number | K113821 |
| Device Name: | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | TRANSONIC SYSTEMS, INC. 34 Dutch Mill Rd Ithaca, NY 14850 |
| Contact | Naveen Thuramalla |
| Correspondent | Naveen Thuramalla TRANSONIC SYSTEMS, INC. 34 Dutch Mill Rd Ithaca, NY 14850 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-27 |
| Decision Date | 2012-09-07 |
| Summary: | summary |