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 |