Device Classification Name |
Mechanical Ventilator
|
510(k) Number |
K152664 |
Device Name |
TAV System |
Applicant |
New Aera, Inc. |
2400 Camino Ramon, Suite 365 |
Ramon,
CA
94583
|
|
Applicant Contact |
ERIC JOHANSSON |
Correspondent |
New Aera, Inc. |
2400 Camino Ramon, Suite 365 |
Ramon,
CA
94583
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 09/17/2015 |
Decision Date | 12/02/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|