The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc., Ultrasound Di with the FDA for Siemens Diagnostic Ultrasound Systems.
Device ID | K072090 |
510k Number | K072090 |
Device Name: | SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI 1230 SHOREBIRD WAY Mountain View, CA 94043 |
Contact | Kristen Dorrough |
Correspondent | Kristen Dorrough SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI 1230 SHOREBIRD WAY Mountain View, CA 94043 |
Product Code | IYN |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-30 |
Decision Date | 2007-09-14 |
Summary: | summary |