Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K190254 |
Device Name |
Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask |
Applicant |
Sleepnet Corporation |
5 Merrill Industrial Drive |
Hampton,
NH
03842
|
|
Applicant Contact |
Jennifer Kennedy |
Correspondent |
Sleepnet Corporation % ProMedic, LLC |
131 Bay Point Dr NE |
St. Petersburg,
FL
33704
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 02/07/2019 |
Decision Date | 07/05/2019 |
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
|
|
|