The following data is part of a premarket notification filed by Neurologica Corporation, A Subsidiary Of with the FDA for Gmr40.
| Device ID | K171085 |
| 510k Number | K171085 |
| Device Name: | GMR40 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | NeuroLogica Corporation, A Subsidiary Of Samsung Electronics Co., Ltd 14 Electronics Avenue Danvers, MA 01923 |
| Contact | Ninad Gujar |
| Correspondent | Ninad Gujar NeuroLogica Corporation, A Subsidiary Of Samsung Electronics Co., Ltd 14 Electronics Avenue Danvers, MA 01923 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-12 |
| Decision Date | 2017-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815411020298 | K171085 | 000 |