The following data is part of a premarket notification filed by Echocath, Inc. with the FDA for Echoflow Doppler Blood Velocity Meter.
| Device ID | K990642 |
| 510k Number | K990642 |
| Device Name: | ECHOFLOW DOPPLER BLOOD VELOCITY METER |
| Classification | Transducer, Ultrasonic |
| Applicant | ECHOCATH, INC. 4326 U.S. ROUTE #1 Monmouth Junction, NJ 08852 |
| Contact | Geprge Myers |
| Correspondent | Geprge Myers ECHOCATH, INC. 4326 U.S. ROUTE #1 Monmouth Junction, NJ 08852 |
| Product Code | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-26 |
| Decision Date | 1999-09-16 |
| Summary: | summary |