FDA 510(k)

RESTING EKG ELECTRODE SERIES

K-Number: K910494 · 1991-04-22

ApplicantMedtronic Andover Medical, Inc.

Decision Date1991-04-22

Product CodeDRX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

RESTING EKG ELECTRODE SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Andover Medical, Inc.. It received FDA 510(k) clearance on 1991-04-22 under 510(k) number K910494. 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 RESTING EKG ELECTRODE SERIES?

RESTING EKG ELECTRODE SERIES is a medical device that received FDA 510(k) clearance on 1991-04-22. The listed applicant is Medtronic Andover Medical, Inc.. The 510(k) number is K910494.

When did RESTING EKG ELECTRODE SERIES receive FDA 510(k) clearance?

RESTING EKG ELECTRODE SERIES received FDA 510(k) clearance on 1991-04-22, under 510(k) number K910494.

Who is the listed applicant for RESTING EKG ELECTRODE SERIES?

The FDA 510(k) record lists Medtronic Andover Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESTING EKG ELECTRODE SERIES?

The FDA product code for RESTING EKG ELECTRODE SERIES is DRX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medtronic Andover Medical, Inc. as applicant

K905446MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE K903018MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002 K903554NORTECH MODEL 87202204 ELECTRODE K882174MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE K852469SAF-D-FIB

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

View on FDA Database →

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