The following data is part of a premarket notification filed by Biosound, Inc. with the FDA for Genesis Ii 7.5mhz Ultrasound Transducer.
Device ID | K881723 |
510k Number | K881723 |
Device Name: | GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER |
Classification | Transducer, Ultrasonic |
Applicant | BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250 |
Contact | Robert Courtney |
Correspondent | Robert Courtney BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250 |
Product Code | JOP |
CFR Regulation Number | 870.2880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-21 |
Decision Date | 1988-08-12 |