DRL · Class II · 21 CFR 870.5325

FDA Product Code DRL: Tester, Defibrillator

Leading manufacturers include Netech Corporation, Instrumentation Laboratory CO and Seaward Group.

19

Total

19

Cleared

119d

Avg days

1978

Since

FDA 510(k) Cleared Tester, Defibrillator Devices (Product Code DRL)

19 devices

1–19 of 19

Cleared Aug 28, 2019

Netech Corporation

Cardiovascular · 187d

Cleared Dec 14, 2018

Cardiovascular · 59d

Cleared Dec 15, 1978

CARDIAC CARE Q/C TEST KIT

Instrumentation Laboratory CO

Cardiovascular · 9d

About Product Code DRL - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,218 total devices indexed.

Latest clearance: Aug 28, 2019

Product Code Info

Code	DRL
Device class	Class II
CFR	21 CFR 870.5325
Panel	Cardiovascular

Verify on FDA.gov

View DRL classification on FDA.gov →