Duns Number:730624095
Device Description: The CPRmeter™ CPR feedback device is used as a guide in administering CPR to a suspected s 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.
Catalog Number
801-00149
Brand Name
CPRmeter
Version/Model Number
801
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 30, 2016
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K122050
Product Code
LIX
Product Code Name
Aid, Cardiopulmonary Resuscitation
Public Device Record Key
47b4fe44-cb97-45b2-8d6f-6cfb68d5ce7d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 22, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 80 |