FIRMM
System, Nuclear Magnetic Resonance Imaging
Nous Imaging, Inc.
The following data is part of a premarket notification filed by Nous Imaging, Inc. with the FDA for Firmm.
Pre-market Notification Details
| Device ID | K201141 |
| 510k Number | K201141 |
| Device Name: | FIRMM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Nous Imaging, Inc. 4220 Duncan Ave St. Louis, MO 63108 |
| Contact | Todd Deckard |
| Correspondent | Rob Newman Scion Opportunity Consulting 680 Webb Road Chadds Ford, PA 19317 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-29 |
| Decision Date | 2020-08-26 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860004785101 | K201141 | 000 |
Trademark Results [FIRMM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIRMM 88020797 5675291 Live/Registered |
NOUS IMAGING, INC. 2018-06-29 |
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