The following data is part of a premarket notification filed by Echocath, Inc. with the FDA for Echoflow Portable Doppler Blood Flow Measurement System; Model Pef-1.
| Device ID | K010482 |
| 510k Number | K010482 |
| Device Name: | ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 |
| Classification | Transducer, Ultrasonic |
| Applicant | ECHOCATH, INC. 4326 U.S. ROUTE #1 Monmouth Junction, NJ 08852 |
| Contact | David Lyons |
| Correspondent | David Lyons ECHOCATH, INC. 4326 U.S. ROUTE #1 Monmouth Junction, NJ 08852 |
| Product Code | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-20 |
| Decision Date | 2001-03-20 |