Zoll E Series with Real CPR Help
510(k) K062177
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK062177 | Date13 Dec 2006 | 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- Withdrawn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 E Series with Real CPR Help is an Automated External Defibrillator (Non-Wearable) designed to deliver life-saving electrical shocks and provide real-time feedback during cardiopulmonary resuscitation (CPR). It combines defibrillation capabilities with advanced CPR guidance, including compression rate, depth, and recoil metrics, to optimize resuscitation efforts in cardiac arrest scenarios. The device is engineered for use by trained responders, including first responders, healthcare professionals, and lay rescuers in prehospital and emergency settings.
The Zoll E Series is supplied as a reusable medical device, intended for use in environments where immediate defibrillation and CPR assistance are required, such as ambulances, emergency rooms, and public access defibrillation programs. It operates in Class III regulatory classification under FDA 510(k) clearance (K062177) and adheres to FDA regulation 870.5310. The device is not MRI-compatible and must be stored in a clean, dry environment as per manufacturer instructions to maintain functionality and sterility where applicable. Multiple model variants are listed under registration numbers and FEI identifiers, reflecting variations in software or firmware updates.