The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Acuson V510 Transducer.
Device ID | K911767 |
510k Number | K911767 |
Device Name: | ACUSON V510 TRANSDUCER |
Classification | Transducer, Ultrasonic, Diagnostic |
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 | ITX |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-19 |
Decision Date | 1991-10-31 |