The following data is part of a premarket notification filed by Siemens Medical Solution with the FDA for Acuson S3000 Diagnostic Ultrasound System.
Device ID | K121138 |
510k Number | K121138 |
Device Name: | ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | SIEMENS MEDICAL SOLUTION 1230 SHOREBIRD WAY Mountainview, CA 94043 |
Contact | Shelly Pearce |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | IYN |
Subsequent Product Code | ITX |
Subsequent Product Code | IYO |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2012-04-13 |
Decision Date | 2012-05-17 |
Summary: | summary |