Zoll M Series with Real CPR Help
510(k) K062537
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK062537 | Date28 Feb 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MKJ
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.5310
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Zoll M Series with Real CPR Help is an Automated External Defibrillator (Non-Wearable), designed to deliver life-saving electrical shocks and provide real-time feedback to improve the quality of chest compressions during cardiopulmonary resuscitation (CPR). It combines defibrillation capabilities with advanced CPR guidance to enhance resuscitation efforts in both pre-hospital and in-hospital settings, ensuring synchronized therapy for improved patient outcomes.
This device is supplied as a reusable medical instrument, intended for use by trained healthcare professionals and emergency responders. It operates in environments where immediate cardiac intervention is required, such as emergency rooms, ambulances, and public access defibrillation sites. The Zoll M Series is classified as a Class III device under FDA regulations (870.5310) and holds a Traditional 510(k) clearance (K062537) with an advisory committee review in Cardiovascular. Storage and maintenance follow manufacturer guidelines to ensure proper functionality and sterility where applicable.
Other devices from Zoll Medical Corporation
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the Zoll M Series with Real CPR Help in a resuscitation scenario?
The Zoll M Series with Real CPR Help is designed to deliver life-saving electrical shocks during sudden cardiac arrest, functioning as an Automated External Defibrillator (Non-Wearable). Beyond defibrillation, it provides real-time feedback to optimize chest compression quality during CPR, ensuring synchronized therapy for better patient outcomes in both pre-hospital and in-hospital settings.
Is the Zoll M Series intended for single-use or reusable applications, and who is it meant for?
The Zoll M Series is a reusable medical instrument, intended exclusively for trained healthcare professionals and emergency responders. Its design and regulatory classification (Class III) reflect its use in high-stakes environments like emergency rooms, ambulances, and public access defibrillation sites, where repeated deployments are necessary.
How does the Zoll M Series differ from standard defibrillators in terms of functionality?
Unlike standard defibrillators, the Zoll M Series combines defibrillation capabilities with advanced CPR guidance. It offers real-time feedback to improve the quality of chest compressions, helping rescuers deliver synchronized therapy and potentially improving survival rates during cardiac emergencies.
What regulatory pathway was followed for the Zoll M Series, and what does this imply for its use?
The Zoll M Series received a Traditional 510(k) clearance (K062537) through the FDA’s pathway for Class III devices, with an advisory committee review in Cardiovascular. This implies it underwent rigorous evaluation for safety and effectiveness, ensuring it meets stringent standards for use in critical cardiac interventions by authorized personnel.
Are there specific storage or maintenance requirements for the Zoll M Series?
While the provided data does not detail exact storage conditions, the device’s reusable nature and regulatory classification (Class III) necessitate adherence to manufacturer guidelines for proper functionality and longevity. Maintenance should follow protocols outlined by Zoll Medical Corporation to ensure reliability in emergency scenarios.