FDA 510(k)

DISPOSAL ECG ELECTRODES, MODEL EASYRODE

K-Number: K092389 · 2009-10-13

Decision Date2009-10-13

Product CodeDRX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DISPOSAL ECG ELECTRODES, MODEL EASYRODE is the device name listed in this FDA 510(k) record. The listed applicant is Suzuken Co., Ltd.. It received FDA 510(k) clearance on 2009-10-13 under 510(k) number K092389. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSAL ECG ELECTRODES, MODEL EASYRODE?

DISPOSAL ECG ELECTRODES, MODEL EASYRODE is a medical device that received FDA 510(k) clearance on 2009-10-13. The listed applicant is Suzuken Co., Ltd.. The 510(k) number is K092389.

When did DISPOSAL ECG ELECTRODES, MODEL EASYRODE receive FDA 510(k) clearance?

DISPOSAL ECG ELECTRODES, MODEL EASYRODE received FDA 510(k) clearance on 2009-10-13, under 510(k) number K092389.

Who is the listed applicant for DISPOSAL ECG ELECTRODES, MODEL EASYRODE?

The FDA 510(k) record lists Suzuken Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSAL ECG ELECTRODES, MODEL EASYRODE?

The FDA product code for DISPOSAL ECG ELECTRODES, MODEL EASYRODE is DRX.

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Other records listing Suzuken Co., Ltd. as applicant

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Related Devices (Code: DRX)

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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.