Zoll E Series

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K111594 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Propaq MD

  Class III

  FDA 510(k) K112761 Active Cleared 25 Apr 2012

• Zoll Propaq Md

  Class II

  FDA 510(k) K102468 Active Cleared 30 Sep 2010

• Zoll E Series with CPRReadyCharge

  Class III

  FDA 510(k) K091265 Active Cleared 23 Dec 2009

• Zoll E Series Defibrillator

  Class III

  FDA 510(k) K072923 Active Cleared 24 Apr 2008

• Zoll E Series with Bluetooth Dial Up Networking

  Class III

  FDA 510(k) K081081 Active Cleared 9 Mar 2009

• Zoll R Series with 2010 Aha Guidelines Software Update

  Class III

  FDA 510(k) K110361 Active Cleared 8 Mar 2011

See all devices from Zoll Medical Corporation, World Wide Headquarters →

• Is the Zoll E Series designed for single-use or reusable applications in emergency settings?

  The Zoll E Series is a reusable medical device, not intended for single-use. It requires proper calibration, maintenance, and periodic servicing as outlined by the manufacturer to ensure reliable performance in pre-hospital, emergency medical, and public-access settings.

• What advanced features does the Zoll E Series include to assist in resuscitation efforts?

  The Zoll E Series incorporates a 12-lead ECG capability for detailed cardiac assessment, voice prompts to guide rescuers through resuscitation steps, and adaptive energy delivery to optimize the effectiveness of defibrillation shocks during sudden cardiac arrest.

• How is the Zoll E Series regulated, and what does this mean for its use in clinical settings?

  The Zoll E Series holds FDA 510(k) clearance under the classification of Class III medical devices, adhering to strict regulatory standards for cardiovascular emergency response equipment. This means it has undergone rigorous evaluation to ensure safety and effectiveness, allowing its use in pre-hospital, emergency medical, and public-access settings as intended.

• What types of environments is the Zoll E Series intended for, and who can operate it?

  The Zoll E Series is designed for pre-hospital, emergency medical, and public-access settings where trained responders or laypersons may administer defibrillation. Its intuitive features, such as voice prompts, make it accessible for use by individuals with varying levels of medical training.

• Does the Zoll E Series require any special handling or storage conditions?

  While the device itself is reusable, it must be stored in a clean, dry environment to prevent damage or contamination. The manufacturer’s guidelines specify proper calibration, maintenance, and periodic servicing to ensure optimal performance, but no specific storage conditions (like temperature or humidity) are mentioned in the provided data.