The following data is part of a premarket notification filed by Transonic Systems, Inc. with the FDA for Transonic Tissue Perfusion Monitor.
| Device ID | K140740 |
| 510k Number | K140740 |
| Device Name: | TRANSONIC TISSUE PERFUSION MONITOR |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | TRANSONIC SYSTEMS, INC. 34 DUTCH MILL RD. Ithaca, NY 14850 |
| Contact | David Klementowski |
| Correspondent | Leah Van De Water TRANSONIC SYSTEMS, INC. 34 DUTCH MILL RD. Ithaca, NY 14850 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-25 |
| Decision Date | 2015-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00877466000543 | K140740 | 000 |
| 00877466000536 | K140740 | 000 |
| 00877466000529 | K140740 | 000 |
| 00877466000512 | K140740 | 000 |
| 00877466000505 | K140740 | 000 |
| 00877466000499 | K140740 | 000 |
| 00877466000550 | K140740 | 000 |
| 08774660000503 | K140740 | 000 |
| 08774660000497 | K140740 | 000 |