CPRmeter

The CPRmeter™ CPR feedback device is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim. The feedback is provided in accordance with the 2010 versions of…

Registry build 21.09.26

The CPRmeter™ CPR feedback device is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim. The feedback is provided in accordance with the 2010 versions of the guidelines for resuscitation published by the International Liaison Committee on Resuscitation (ILCOR), American Heart Association (AHA), and European Resuscitation Council (ERC) (hereinafter referred to as “CPR Guidelines”). The CPRmeter device is intended for use by responders who have been trained in CPR and use of the CPRmeter device. The CPRmeter device provides feedback on CPR via a display panel to improve responders’ compliance with CPR Guidelines.

2manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code

Who Else Makes It

All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LIX
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Amphenol Alden Products Company Shenzhen Guangdong Contract manufacturer 24

Record

Regulatory record for CPRmeter
Listed by Laerdal Medical Corp., United States
FDA product code LIX
Device type Aid, Cardiopulmonary Resuscitation
Device class Class 2
Regulation 21 CFR 870.5210
510(k) K122050
Record published 2014-10-22
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries serial number
Storage Storage environment humidity 5 to 75 % RH; Storage environment temperature -20 to 70 °C
Distribution end date 2016-11-30

Catalogue Numbers

Catalogue numbers for CPRmeter
Catalogue number Size Status
801 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Pocketcpr Zoll Medical Corporation 3
Moore Medical Moore Medical Corp. 2
TrueCPR™ Coaching Device Physio-Control, Inc. 2
Intellisense Adult Defibrillation Pads,CPR Device, Powerheart® G5 Zoll Medical Corporation 1
CPRmeter 2 (Multi-bundle) Laerdal Medical Corp. 1
Onestep Pediaric CPR Multi-Function Electrode, SIN Zoll Medical Corporation 1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K183348 2018-12-17
K173886 2018-03-23
K151702 2015-08-13

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer