Device Classification Name |
Ventilator, Emergency, Powered (Resuscitator)
|
510(k) Number |
K093862 |
Device Name |
CAREVENT HANDHELD CPAP SYSTEM |
Applicant |
O-TWO MEDICAL TECHNOLOGIES, INC. |
7575 KIMBEL ST. |
MISSISSAUGA, ONTARIO,
CA
L5S 1C8
|
|
Applicant Contact |
David Zhang |
Correspondent |
O-TWO MEDICAL TECHNOLOGIES, INC. |
7575 KIMBEL ST. |
MISSISSAUGA, ONTARIO,
CA
L5S 1C8
|
|
Correspondent Contact |
David Zhang |
Regulation Number | 868.5925
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/17/2009 |
Decision Date | 05/06/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|