Device Classification Name |
Calculator, Pulmonary Function Data
|
510(k) Number |
K161295 |
Device Name |
MiniBox + |
Applicant |
PULMONE ADVANCED MEDICAL DEVICES, LTD |
14 HACHAROSHET ST |
Ra’ananna,
IL
4365707
|
|
Applicant Contact |
Avi Lazar |
Correspondent |
SFA CONSULTING, LLC |
200 PARK AVENUE, UNIT 111 |
MINNEAPOLIS,
MN
55415
|
|
Correspondent Contact |
Susan Alpert |
Regulation Number | 868.1880 |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/09/2016 |
Decision Date | 10/21/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|