Device Classification Name |
ventilator, emergency, powered (resuscitator)
|
510(k) Number |
K051469 |
Device Name |
CAREVENT ATV+ AND CAREVENT MRI |
Applicant |
O-TWO MEDICAL TECHNOLOGIES, INC. |
7575 KIMBEL ST. |
MISSISSAUGA, ONTARIO,
CA
L5S 1C8
|
|
Applicant Contact |
AMMAR AL-DOJALLY |
Correspondent |
O-TWO MEDICAL TECHNOLOGIES, INC. |
7575 KIMBEL ST. |
MISSISSAUGA, ONTARIO,
CA
L5S 1C8
|
|
Correspondent Contact |
AMMAR AL-DOJALLY |
Regulation Number | 868.5925
|
Classification Product Code |
|
Date Received | 06/03/2005 |
Decision Date | 09/28/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|