The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Multix Select Dr.
Device ID | K132934 |
510k Number | K132934 |
Device Name: | MULTIX SELECT DR |
Classification | System, X-ray, Stationary |
Applicant | SIEMENS MEDICAL SOLUTIONS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 |
Contact | Patricia D Jones |
Correspondent | Patricia D Jones SIEMENS MEDICAL SOLUTIONS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-09-18 |
Decision Date | 2014-04-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04056869006925 | K132934 | 000 |