The following data is part of a premarket notification filed by Thornhill Research Inc with the FDA for Moves Slc.
Device ID | K140049 |
510k Number | K140049 |
Device Name: | MOVES SLC |
Classification | Ventilator, Emergency, Powered (resuscitator) |
Applicant | THORNHILL RESEARCH INC 210 DUNDAS STREET WEST Toronto, CA M5g2e8 |
Contact | Cliff Ansel |
Correspondent | Cliff Ansel THORNHILL RESEARCH INC 210 DUNDAS STREET WEST Toronto, CA M5g2e8 |
Product Code | BTL |
CFR Regulation Number | 868.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-01-09 |
Decision Date | 2014-05-29 |
Summary: | summary |