Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K130037 |
Device Name |
BREATHE CPAP SYSTEM |
Applicant |
BREATHE TECHNOLOGIES, INC. |
175 Technology Dr Ste 100 |
Irvine,
CA
92618
|
|
Applicant Contact |
CRAIG COOMBS |
Correspondent |
BREATHE TECHNOLOGIES, INC. |
175 Technology Dr Ste 100 |
Irvine,
CA
92618
|
|
Correspondent Contact |
CRAIG COOMBS |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 01/07/2013 |
Decision Date | 05/17/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|