The following data is part of a premarket notification filed by Cook Vascular, Inc. with the FDA for Cook-swartz Doppler Flow Probe.
| Device ID | K022649 |
| 510k Number | K022649 |
| Device Name: | COOK-SWARTZ DOPPLER FLOW PROBE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | COOK VASCULAR, INC. RT. 66, RIVER RD. P.O. BOX 529 Leechburg, PA 15656 -0529 |
| Contact | Thomas J Kardos |
| Correspondent | Thomas J Kardos COOK VASCULAR, INC. RT. 66, RIVER RD. P.O. BOX 529 Leechburg, PA 15656 -0529 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-09 |
| Decision Date | 2002-09-06 |
| Summary: | summary |