FDA 510(k)

5000 SERIES ECG ELECTRODES

K-Number: K854757 · 1986-04-23

ApplicantAlternative Design Systems, Inc.

Decision Date1986-04-23

Product CodeDRX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

5000 SERIES ECG ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Alternative Design Systems, Inc.. It received FDA 510(k) clearance on 1986-04-23 under 510(k) number K854757. 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 5000 SERIES ECG ELECTRODES?

5000 SERIES ECG ELECTRODES is a medical device that received FDA 510(k) clearance on 1986-04-23. The listed applicant is Alternative Design Systems, Inc.. The 510(k) number is K854757.

When did 5000 SERIES ECG ELECTRODES receive FDA 510(k) clearance?

5000 SERIES ECG ELECTRODES received FDA 510(k) clearance on 1986-04-23, under 510(k) number K854757.

Who is the listed applicant for 5000 SERIES ECG ELECTRODES?

The FDA 510(k) record lists Alternative Design Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 5000 SERIES ECG ELECTRODES?

The FDA product code for 5000 SERIES ECG ELECTRODES is DRX.

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Other records listing Alternative Design Systems, Inc. as applicant

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Related Devices (Code: DRX)

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology Corporation K101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process Sas K100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/S K093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

Official Source

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