The following data is part of a premarket notification filed by Vascular Control Systems, Inc with the FDA for Vcs Doppler Transceiver, Model 09-0023-01.
| Device ID | K052209 |
| 510k Number | K052209 |
| Device Name: | VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | VASCULAR CONTROL SYSTEMS, INC 32236 PASEO ADELANTO, STE. F San Juan Capistrano, CA 92675 |
| Contact | Kathleen Roberts |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-08-15 |
| Decision Date | 2005-09-06 |
| Summary: | summary |