The following data is part of a premarket notification filed by Nemaris Inc with the FDA for Surgimap.
| Device ID | K141669 |
| 510k Number | K141669 |
| Device Name: | SURGIMAP |
| Classification | System, Image Processing, Radiological |
| Applicant | NEMARIS INC 1425 K STREET N.W. 11TH FLOOR Washington, DC 20005 |
| Contact | Keith Barritt |
| Correspondent | Keith Barritt NEMARIS INC 1425 K STREET N.W. 11TH FLOOR Washington, DC 20005 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-23 |
| Decision Date | 2014-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859699006059 | K141669 | 000 |
| 00859699006042 | K141669 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SURGIMAP 77123471 3651682 Live/Registered |
NEMARIS, INC. 2007-03-06 |