Medical Device Manufacturer · US , Warrington , PA

Ni Medical - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1997

Recent clearances: BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM, NICAS(TM) ELECTRODE

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ni Medical Cardiovascular ✕

2 devices

1-2 of 2

Cleared Jul 16, 2007

BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM

Cardiovascular · 145d

Cleared Jul 08, 1997

NICAS(TM) ELECTRODE

Cardiovascular · 39d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 07, 2026