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ELI 150c ELI150c-AAA-AAAAX

by Mortara Instrument, Inc.

ELI 150c ELI150c-AAA-AAAAX is a Class II device made by Mortara Instrument, Inc., cleared under FDA 510(k) K101115 on 18 Jun 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00812345025330), active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K101115

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00812345025330 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK101115 Date18 Jun 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K101115 decided 18 Jun 2010 Active
  • FDA GUDID UDI-DI 00812345025330 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1810-2020 FDA Class II initiated 18 Mar 2020

    Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

Timeline

3 dated events

  1. Cleared FDA 510(k) K101115
  2. Listed FDA GUDID 00812345025330
  3. Recall initiated FDA recalls Z-1810-2020

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ELI 150c
Generic name
Electrocardiograph, professional, multichannel
Model / reference
ELI150c-AAA-AAAAX
Primary DI / UDI-DI
00812345025330
510(k) Number
FDA product code
DPS
GMDN term
Electrocardiograph, professional, multichannel
Device class
Class II
Regulation number
870.2340
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrocardiograph, professional, multichannel

Cleared under the same submission (K101115)

and 8 more cleared under K101115

Similar devices in this category

Other devices filed under Electrocardiograph, professional, multichannel.

Other devices from Mortara Instrument, Inc.

See all devices from Mortara Instrument, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)