Medical Device Manufacturer · US , Minneapolis , MN

Nk Biotechnical Engineering Co. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 1991

15

Total

15

Cleared

0

Denied

FDA 510(k) Regulatory Record - Nk Biotechnical Engineering Co. Neurology ✕

14 devices

1-12 of 14

Cleared Aug 11, 1994

NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001

Neurology · 338d

Cleared May 12, 1993

NK GRASP SENSOR, MODEL GA001

Neurology · 278d

Cleared May 12, 1993

NK GRASP SENSOR, MODEL GA002

Neurology · 278d

Cleared Mar 31, 1993

NK DIGI-GRIP SENSOR, MODEL DGR001

Neurology · 236d

Cleared Jul 14, 1992

NK DYNA-GRIP SENSOR, MODEL DG001

Neurology · 120d

Cleared Dec 09, 1991

NK GRASP SENSOR, MODEL GR001

Neurology · 90d

Cleared Dec 09, 1991

PINCH SENSOR, MODEL PF001

Neurology · 90d

Cleared Dec 09, 1991

NK PINCH SENSOR, MODEL PF002

Neurology · 90d

Cleared Dec 09, 1991

NK PINCH SENSOR, MODEL PA001

Neurology · 90d

Cleared Dec 09, 1991

NK DEVIATION SENSOR, MODEL DV001

Neurology · 90d

Cleared Dec 09, 1991

RANGE OF MOTION SENSOR, MODEL RM001

Neurology · 90d

Cleared Dec 09, 1991

NK RANGE OF MOTION SENSOR, MODEL RM002

Neurology · 90d