Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K121747 |
Device Name |
FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS |
Applicant |
INTERSURGICAL INCORPORATED |
417 ELECTRONICS PARKWAY |
LIVERPOOL,
NY
13088
|
|
Applicant Contact |
MICHAEL ZALEWSKI |
Correspondent |
INTERSURGICAL INCORPORATED |
417 ELECTRONICS PARKWAY |
LIVERPOOL,
NY
13088
|
|
Correspondent Contact |
MICHAEL ZALEWSKI |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 06/14/2012 |
Decision Date | 03/14/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|