Medical Device Manufacturer · US , Budd Lake , NJ

Hi-Tronics Designs, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1995

Recent clearances: MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR, MEMORYTRACE ATM MODEL 4222

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hi-Tronics Designs, Inc. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Jan 02, 1998

MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR

Cardiovascular · 85d

Cleared Jun 26, 1995

MEMORYTRACE ATM MODEL 4222

Cardiovascular · 434d