The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Cios Select.
Device ID | K181767 |
510k Number | K181767 |
Device Name: | Cios Select |
Classification | Interventional Fluoroscopic X-ray System |
Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard 65-1A Malvern, PA 19355 |
Contact | Patricia D. Jones |
Correspondent | Patricia D. Jones Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard 65-1A Malvern, PA 19355 |
Product Code | OWB |
Subsequent Product Code | JAA |
Subsequent Product Code | OXO |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-07-03 |
Decision Date | 2018-08-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04056869148243 | K181767 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CIOS SELECT 79151434 4705976 Live/Registered |
Siemens Healthcare GmbH 2014-07-24 |