Device Classification Name |
Ventilator, Continuous, Non-Life-Supporting
|
510(k) Number |
K240778 |
Device Name |
Vivo 1, Vivo 2 |
Applicant |
Breas Medical AB |
Foretagsvagen 1 |
Molnlycke,
SE
45333
|
|
Applicant Contact |
Ivan Liljegren |
Correspondent |
OConnell Regulatory Consultants, Inc. |
44 Oak Street |
Stoneham,
MA
02180
|
|
Correspondent Contact |
Maureen OConnell |
Regulation Number | 868.5895
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/21/2024 |
Decision Date | 12/13/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|