Medical Device Manufacturer · US , Mchenry , IL

Fukuda Denshi USA, Inc. - FDA 510(k) Cleared Devices

68 submissions · 68 cleared · Since 1984

68

Total

68

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fukuda Denshi USA, Inc. Anesthesiology ✕

9 devices

1-9 of 9

Cleared Dec 20, 2001

FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE

Anesthesiology · 80d

Cleared Jun 12, 1998

FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE

Anesthesiology · 87d

Cleared Sep 15, 1995

FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE

Anesthesiology · 253d

Cleared Feb 01, 1995

FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE

Anesthesiology · 86d

Cleared Apr 01, 1994

FUKUDA DENSHI MODEL HG-301

Anesthesiology · 736d

Cleared Jan 15, 1993

FUKUDA DENSHI MODEL SPIROSIFT SP-5000

Anesthesiology · 238d

Cleared May 22, 1991

Anesthesiology · 252d

Cleared Apr 10, 1990

FUKUDA DENSHI MODEL SPIROSIFT 3000

Anesthesiology · 74d

Cleared Jan 12, 1990

MODIFIED SPIROSCAN 1000

Anesthesiology · 23d