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 |