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PC ECG Model SE-1010

by Edan Instruments, Inc.

510(k) K092010

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K092010↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK092010 Date22 Oct 2009ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
DPS
Device class
Class II
Regulation
21 CFR Part 870.2340
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PC ECG Model SE-1010 is a portable, 12-channel electrocardiograph designed for recording and analyzing cardiac electrical activity. It functions as a diagnostic device to capture and display ECG waveforms, enabling clinicians to assess heart rhythm, detect abnormalities, and monitor cardiac health in clinical or ambulatory settings.

This device is supplied as a reusable, non-sterile medical instrument intended for use in healthcare facilities. It operates in environments where MRI safety is not a primary concern, as no specific MRI-compatible features are noted. The device requires standard electrical power and is regulated under FDA 510(k) clearance and MDR compliance, ensuring adherence to established safety and performance standards for electrocardiographic equipment.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Is the PC ECG Model SE-1010 designed for single-use or can it be reused in a clinical setting?

    The PC ECG Model SE-1010 is explicitly described as a reusable medical instrument. Since it is non-sterile and intended for use in healthcare facilities, it must be cleaned and maintained according to manufacturer guidelines between patient uses to ensure proper functionality and infection control.

  • What types of environments is this device intended for, and are there any special safety considerations?

    The PC ECG Model SE-1010 is designed for clinical or ambulatory settings where MRI safety is not a primary concern. The device does not specify MRI compatibility, so it should not be used in MRI environments unless explicitly verified by the manufacturer for such settings. Standard electrical power is required for operation.

  • How many ECG leads does this device support, and what is its primary clinical purpose?

    The PC ECG Model SE-1010 is a 12-channel electrocardiograph, meaning it captures electrical activity from 12 different lead positions on the heart. Its primary purpose is to record and analyze cardiac electrical activity, allowing clinicians to assess heart rhythm, detect abnormalities, and monitor overall cardiac health.

  • What regulatory pathways does this device follow, and which committee reviewed its submission?

    The PC ECG Model SE-1010 is regulated under FDA 510(k) clearance and MDR compliance, with a substantially equivalent determination by the FDA. Its submission was reviewed by the Cardiovascular (CV) Advisory Committee as part of the traditional 510(k) process, ensuring it meets established safety and performance standards for electrocardiographic devices.