The following data is part of a premarket notification filed by Siemens Healthcare with the FDA for Acuson S3000 S2000 S1000 Diagnostic Ultrasound Systems.
Device ID | K172162 |
510k Number | K172162 |
Device Name: | ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | Siemens Healthcare 22010 SE 51st St Issaquah, WA 98029 |
Contact | Jessica Stenberg |
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 |
Subsequent Product Code | OBJ |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2017-07-18 |
Decision Date | 2017-08-16 |
Summary: | summary |