The following data is part of a premarket notification filed by Thornhill Research Inc. with the FDA for Moves Slc.
| Device ID | K161420 |
| 510k Number | K161420 |
| Device Name: | MOVES SLC |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | THORNHILL RESEARCH INC. 210 DUNDAS STREET WEST, SUITE 200 Toronto, CA M5g 2e8 |
| Contact | Kipton Lade |
| Correspondent | Kipton Lade THORNHILL RESEARCH INC. 210 DUNDAS STREET WEST, SUITE 200 Toronto, CA M5g 2e8 |
| Product Code | BTL |
| Subsequent Product Code | BTA |
| Subsequent Product Code | CAW |
| Subsequent Product Code | MWI |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-23 |
| Decision Date | 2017-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10807141000121 | K161420 | 000 |
| 10807141000114 | K161420 | 000 |