Medical Device Manufacturer · US , Mchenry , IL

Kone Instruments, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1982

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Kone Instruments, Inc. Cardiovascular ✕

8 devices

1-8 of 8

Cleared Dec 22, 1986

M700 STRESS MONITOR

Cardiovascular · 105d

Cleared Aug 06, 1986

SIGNA II RESTING ECG ELECTRODE

Cardiovascular · 23d

Cleared Apr 23, 1986

MODEL E 600 ELECTROCARDIOGRAPH

Cardiovascular · 51d

Cleared Oct 11, 1985

Cardiovascular · 60d

Cleared Mar 24, 1983

CENTRAL STATION 590

Cardiovascular · 43d

Cleared Mar 24, 1983

PATIENT MONITOR 575

Cardiovascular · 43d

Cleared Nov 01, 1982

Cardiovascular · 28d

Cleared Apr 01, 1982

Cardiovascular · 30d