FDA 510(k)

NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH

K-Number: K972310 · 1997-08-20

Decision Date1997-08-20

Product CodeDPS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 1997-08-20 under 510(k) number K972310. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH?

NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1997-08-20. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K972310.

When did NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1997-08-20, under 510(k) number K972310.

Who is the listed applicant for NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH?

The FDA 510(k) record lists Nihon Kohden America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH?

The FDA product code for NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH is DPS.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.