The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Sensis, Sensis Lite.
| Device ID | K131812 |
| 510k Number | K131812 |
| Device Name: | SENSIS, SENSIS LITE |
| Classification | Computer, Diagnostic, Programmable |
| 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 | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-19 |
| Decision Date | 2013-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869010144 | K131812 | 000 |
| 04056869010137 | K131812 | 000 |