Device Classification Name |
mechanical ventilator
|
510(k) Number |
K082982 |
Device Name |
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES |
Applicant |
BREATHE TECHNOLOGIES, INC. |
1193 SHERMAN ST. |
ALAMEDA,
CA
94501
|
|
Applicant Contact |
CRAIG COOMBS |
Correspondent |
BREATHE TECHNOLOGIES, INC. |
1193 SHERMAN ST. |
ALAMEDA,
CA
94501
|
|
Correspondent Contact |
CRAIG COOMBS |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 10/06/2008 |
Decision Date | 07/20/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|