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 | K080116 |
| 510k Number | K080116 |
| 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 | Mark S Alsberge |
| Correspondent | Mark S Alsberge 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 | 2008-01-16 |
| Decision Date | 2008-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00877466000413 | K080116 | 000 |
| 08774660000343 | K080116 | 000 |
| 08774660000350 | K080116 | 000 |
| 08774660000367 | K080116 | 000 |
| 08774660000275 | K080116 | 000 |
| 08774660000305 | K080116 | 000 |
| 08774660000329 | K080116 | 000 |
| 08774660000411 | K080116 | 000 |
| 08774660005713 | K080116 | 000 |
| 08774660005720 | K080116 | 000 |
| 08774660005737 | K080116 | 000 |
| 08774660005744 | K080116 | 000 |
| 00877466000321 | K080116 | 000 |
| 00877466000338 | K080116 | 000 |
| 00877466000345 | K080116 | 000 |
| 00877466000352 | K080116 | 000 |
| 00877466000369 | K080116 | 000 |
| 08774660000336 | K080116 | 000 |