The following data is part of a premarket notification filed by Acuson Corp. with the FDA for L7 Transducer Used On Aspen Model Ultrasound System.
Device ID | K973079 |
510k Number | K973079 |
Device Name: | L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM |
Classification | Transducer, Ultrasonic, Diagnostic |
Applicant | ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
Contact | William Welch |
Correspondent | William Welch 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 | 1997-08-18 |
Decision Date | 1997-11-05 |
Summary: | summary |