The following data is part of a premarket notification filed by Netech Corporation with the FDA for Delta 3300.
Device ID | K190437 |
510k Number | K190437 |
Device Name: | Delta 3300 |
Classification | Tester, Defibrillator |
Applicant | Netech Corporation 110 Toledo Street Farmingdale, NY 11735 |
Contact | Mohan Das |
Correspondent | Mukesh Kumar Brij Strategic Consultations, LLC 20271 Goldenrod Lane, Suite 2020 Germantown, MD 20876 |
Product Code | DRL |
CFR Regulation Number | 870.5325 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-02-22 |
Decision Date | 2019-08-28 |