The following data is part of a premarket notification filed by Implicity, Inc. with the FDA for Im007.
| Device ID | K210543 |
| 510k Number | K210543 |
| Device Name: | IM007 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Implicity, Inc. 185 Alewife Brook Parkway Suite 210 Cambridge, MA 02138 |
| Contact | David Perlmutter |
| Correspondent | Mark Johnson MJ Medtech Consulting Services LLC 24125 Butteville Rd. NE Aurora, OR 97002 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-24 |
| Decision Date | 2021-11-03 |