Device Classification Name |
tester, defibrillator
|
510(k) Number |
K190437 |
Device Name |
Delta 3300 |
Applicant |
Netech Corporation |
110 Toledo Street |
Farmingdale,
NY
11735
|
|
Applicant Contact |
Mohan Das |
Correspondent |
Brij Strategic Consultations, LLC |
20271 Goldenrod Lane, Suite 2020 |
Germantown,
MD
20876
|
|
Correspondent Contact |
Mukesh Kumar |
Regulation Number | 870.5325
|
Classification Product Code |
|
Date Received | 02/22/2019 |
Decision Date | 08/28/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|