# K190437: Delta 3300

- Pathway: 510(k) (Traditional)
- Applicant: Netech Corporation
- Decided: Aug 28, 2019 after 187 days
- Product code: DRL (Tester, Defibrillator)
- Device class: 2
- Regulation: 21 CFR 870.5325
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K014153 (2002). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110192: Defibrillator Analyzer - DA-2006P, Bc Group International, Inc. (2011) Summary page 4.
- K160761: DW-1C, Dongwon Medical Co., Ltd. (2016) Summary page 5.

## Indications for use
Netech Corporation Delta 3300 Defibrillator/Pacemaker Analyzer is used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output.

Source page: https://510kreport.com/device/K190437
Methodology: https://510kreport.com/methodology