The following data is part of a premarket notification filed by Transonic Systems, Inc. with the FDA for Aureflo Monitoring System.
| Device ID | K112657 |
| 510k Number | K112657 |
| Device Name: | AUREFLO MONITORING SYSTEM |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | TRANSONIC SYSTEMS, INC. 34 DUTCH MILL RD. Ithaca, NY 14850 |
| Contact | David Klementowski |
| Correspondent | David Klementowski 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 | 2011-09-13 |
| Decision Date | 2011-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00877466005647 | K112657 | 000 |
| 08774660005645 | K112657 | 000 |