The following data is part of a premarket notification filed by Acuson Corp. with the FDA for S5192r Transducer.
Device ID | K904951 |
510k Number | K904951 |
Device Name: | S5192R TRANSDUCER |
Classification | Monitor, Fetal Doppler Ultrasound |
Applicant | ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
Contact | Sheila W Pickering |
Correspondent | Sheila W Pickering ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
Product Code | MAA |
CFR Regulation Number | 884.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-02 |
Decision Date | 1991-04-29 |