The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc., Ultrasound Di with the FDA for Acuson S2000 Diagnostic Ultrasound System.
Device ID | K082142 |
510k Number | K082142 |
Device Name: | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI 1230 SHOREBIRD WAY Mountain View, CA 94043 |
Contact | Shelly Pearce |
Correspondent | Shelly Pearce SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI 1230 SHOREBIRD WAY Mountain View, CA 94043 |
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 | No |
Combination Product | No |
Date Received | 2008-07-30 |
Decision Date | 2008-11-13 |
Summary: | summary |