Identity
- Trade Name
- CPRmeter FDA UDI
- Generic Name
- Cardiopulmonary resuscitation feedback device, electronic FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 801 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 801-00149 FDA UDI
- Primary DI / UDI-DI
- 07045432055290 FDA UDI
- 510(k) Number
- K122050 FDA UDI
- FDA Product Code
- LIX FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation feedback device, electronic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5210 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
CPRmeter by Laerdal Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Laerdal Medical Corp.
Sources (1)
- FDA UDI 47b4fe44-cb97-45b2-8d6f-6cfb68d5ce7d 38 fields · synced Jun 8, 2026