Device Classification Name |
Continuous, Ventilator, Home Use
|
510(k) Number |
K193586 |
Device Name |
Vivo 45 LS |
Applicant |
Breas Medical AB |
Foretagsvagen 1 |
Molnlyeke,
SE
SE-453 33
|
|
Applicant Contact |
Ari Sobel |
Correspondent |
O'Connell Regulatory Consultants, Inc. |
44 Oak Street |
Stoneham,
MA
02180
|
|
Correspondent Contact |
Maureen O'Connell |
Regulation Number | 868.5895
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/23/2019 |
Decision Date | 01/27/2021 |
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
|
|
|