The following data is part of a premarket notification filed by Imris, Inc. with the FDA for Neuro Iii-sv.
Device ID | K083137 |
510k Number | K083137 |
Device Name: | NEURO III-SV |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | IMRIS, INC. 16809 BRIARDALE ROAD Rockville, MD 20855 |
Contact | Thomas M Tsakeris |
Correspondent | Thomas M Tsakeris IMRIS, INC. 16809 BRIARDALE ROAD Rockville, MD 20855 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-10-23 |
Decision Date | 2008-12-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00857534006202 | K083137 | 000 |
00857534006196 | K083137 | 000 |