The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Fetal Assessment Cap.
Device ID | K992580 |
510k Number | K992580 |
Device Name: | FETAL ASSESSMENT CAP |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
Contact | William E Welch |
Correspondent | William E Welch ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-02 |
Decision Date | 1999-10-18 |
Summary: | summary |