Device Classification Name |
ventilator, emergency, powered (resuscitator)
|
510(k) Number |
K093261 |
Device Name |
MOVES |
Applicant |
THORNHILL RESEARCH INC |
70 PETER ST. 2ND FL. |
TORONTO, ONTARIO,
CA
M5V 2G5
|
|
Applicant Contact |
CLIFF ANSEL |
Correspondent |
THORNHILL RESEARCH INC |
70 PETER ST. 2ND FL. |
TORONTO, ONTARIO,
CA
M5V 2G5
|
|
Correspondent Contact |
CLIFF ANSEL |
Regulation Number | 868.5925
|
Classification Product Code |
|
Date Received | 10/19/2009 |
Decision Date | 03/26/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|