Device Classification Name |
Continuous, Ventilator, Home Use
|
510(k) Number |
K160481 |
Device Name |
Vivo 60 |
Applicant |
BREAS MEDICAL AB |
FORETAGSVAGEN 1 |
MOLNLYCKE VASTRA GOTALANDS LAN,
SE
435 33
|
|
Applicant Contact |
Albert Cefalo |
Correspondent |
O'CONNELL REGULATORY CONSULTANTS, INC. |
5 TIMBER LANE |
North Reading,
MA
01864
|
|
Correspondent Contact |
Maureen O'Connell |
Regulation Number | 868.5895
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/22/2016 |
Decision Date | 11/09/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|