510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190437Substantially Equivalent

Delta 3300

Netech Corp., Farmingdale NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190437 is the FDA 510(k) clearance record for Delta 3300, a class II device, cleared for Netech Corporation on under FDA product code DRL (Tester, Defibrillator). FDA records list 2 510(k) clearances for Netech Corporation, from to . As of , FDA records show no recalls naming K190437.

Clearance record

Decision date
Received
(187 days to decision)
Product code
DRL Tester, Defibrillator
Regulation
21 CFR 870.5325
Device class
Class II
Review panel
Cardiovascular
Applicant
Netech Corporation 110 Toledo St., Farmingdale NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRL

Trailing 12 months

FDA records hold no clearances under product code DRL in the trailing twelve months.

FDA records show no clearances under product code DRL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260