Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K162041 |
Device Name |
Airworks Nebulizer pe1200m |
Applicant |
Convexity Scientific LLC |
36 Church Lane |
Westport,
CT
06880
|
|
Applicant Contact |
Paul Reiferson |
Correspondent |
mdi Consultants, Inc. |
55 Northern Blvd. |
Great Neck,
NY
11021
|
|
Correspondent Contact |
Susan D. Goldstein-Falk |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 07/25/2016 |
Decision Date | 05/02/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|