NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES

K Number: K990031 · Decision Apr 16, 1999

Classifications

FEI Numbers

Registration Numbers

Same Product Code

Applicant Total

166

Review Days

101

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Device Name: NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES
K Number: K990031
Clearance Type: Traditional
Decision: Substantially Equivalent
Statement or Summary: Summary
Applicant: Nihon Kohden America, Inc.
Date Received: January 5, 1999
Decision Date: April 16, 1999
Product Code: LOS
Advisory Committee: Unknown
Review Advisory Committee: CV
Third Party: N

Other 510(k) clearances with the same product code (LOS), ordered by most recent decision date.

K Number	Device Name	Decision Date	Decision
K113117	NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX	Mar 22, 2012	Substantially Equivalent
K120485	NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P	Mar 16, 2012	Substantially Equivalent
K092573	NIHON KOHDEN QP-160AK EEG TREND PROGRAM	Jul 9, 2010	Substantially Equivalent
K083456	NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P	Mar 2, 2009	Substantially Equivalent
K083271	BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY	Dec 24, 2008	Substantially Equivalent
K082785	NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES	Nov 26, 2008	Substantially Equivalent
K071969	SEN-4100 ELECTRIC STIMULATOR	Oct 6, 2008	Substantially Equivalent
K080546	NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A	Aug 29, 2008	Substantially Equivalent
K073550	PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION	Mar 28, 2008	Substantially Equivalent
K080342	NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES	Feb 26, 2008	Substantially Equivalent