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 |