Device Classification Name |
Cleaner, Air, Medical Recirculating
|
510(k) Number |
K200321 |
Device Name |
Novaerus NV1050 |
Applicant |
Novaerus US Inc |
35 Melrose Place |
Stamford,
CT
06902
|
|
Applicant Contact |
Declan Kiely |
Correspondent |
Novaerus US Inc |
35 Melrose Place |
Stamford,
CT
06902
|
|
Correspondent Contact |
Declan Kiely |
Regulation Number | 880.5045
|
Classification Product Code |
|
Date Received | 02/10/2020 |
Decision Date | 12/28/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|