The following data is part of a premarket notification filed by Cook Vascular, Inc. with the FDA for Doppler Monitor.
| Device ID | K110347 |
| 510k Number | K110347 |
| Device Name: | DOPPLER MONITOR |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | COOK VASCULAR, INC. 1186 MONTGOMERY LANE Vandergrift, PA 15690 |
| Contact | Jim Ferguson |
| Correspondent | Jim Ferguson COOK VASCULAR, INC. 1186 MONTGOMERY LANE Vandergrift, PA 15690 |
| Product Code | DPW |
| Subsequent Product Code | ITX |
| Subsequent Product Code | JOP |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-07 |
| Decision Date | 2011-03-16 |
| Summary: | summary |