Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K161536 |
Device Name |
EasyOne Air Spirometer |
Applicant |
NDD MEDIZINTECHNIK AG |
TECHNOPARKSTRASSE 1 |
ZURICH,
CH
8005
|
|
Applicant Contact |
JERRY MASIELLO |
Correspondent |
NDD MEDICAL TECHNOLOGIES |
300 BRICKSTONE SQUARE, SUITE 604 |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
JERRY MASIELLO |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 06/03/2016 |
Decision Date | 01/05/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|