The following data is part of a premarket notification filed by B-temia Inc. with the FDA for Keeogo Dermoskeleton System.
| Device ID | K201539 |
| 510k Number | K201539 |
| Device Name: | Keeogo Dermoskeleton System |
| Classification | Powered Exoskeleton |
| Applicant | B-Temia Inc. 4780, Rue St-Felix-unite 105 St Augustin De Desmaure, CA G3a 2j9 |
| Contact | Alexandre Jokic |
| Correspondent | Kristin Davenport Covington & Burling LLP 850 10th St NW, Washington, DC 20001 |
| Product Code | PHL |
| CFR Regulation Number | 890.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-09 |
| Decision Date | 2020-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540162060007 | K201539 | 000 |