Device Classification Name |
Calculator, Predicted Values, Pulmonary Function
|
510(k) Number |
K120635 |
Device Name |
EASYONE PRO RESPIRATORY TESTING DEVICE |
Applicant |
NDD MEDIZITECHNIK AG |
TWO DUNDEE PARK |
ANDOVER,
MA
01810
|
|
Applicant Contact |
GERARD MASIELLO |
Correspondent |
NDD MEDIZITECHNIK AG |
TWO DUNDEE PARK |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
GERARD MASIELLO |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 03/01/2012 |
Decision Date | 09/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|