Zoll E Series with Bluetooth Dial Up Networking

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

510(k) Number

K081081 ↗

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 R Series with 2010 Aha Guidelines Software Update

  Class III

  FDA 510(k) K110361 Active Cleared 8 Mar 2011

• Zoll E Series with 2010 Aha Guidlines Software Update

  Class III

  FDA 510(k) K110168 Active Cleared 17 Feb 2011

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

• Is the Zoll E Series with Bluetooth Dial-Up Networking designed for single-use or reusable applications in emergency settings?

  The Zoll E Series with Bluetooth Dial-Up Networking is explicitly described as a reusable medical instrument, intended for use in emergency medical services (EMS) and other challenging environments. This means it is built for repeated use across multiple patients, provided it undergoes proper maintenance and cleaning between deployments.

• How does the Bluetooth connectivity feature of this defibrillator enhance its functionality in the field?

  The Bluetooth Dial-Up Networking capability allows the Zoll E Series to transmit data wirelessly to systems like Zoll’s RescueNet, enabling real-time or delayed integration with field data collection. This facilitates improved patient outcome tracking, remote monitoring, and seamless reporting for EMS teams and healthcare providers.

• What regulatory pathway was followed for FDA clearance of this Automated External Defibrillator?

  The Zoll E Series received FDA 510(k) clearance under the Cardiovascular advisory committee, classified as a Class III medical device (regulation 870.5310). The submission was deemed substantially equivalent to a predicate device, and the clearance was granted via a traditional 510(k) review process in 2009.

• Are there any specific storage or handling requirements mentioned for this reusable defibrillator?

  The provided data does not specify sterility requirements or MRI safety considerations, but since it is a reusable device, proper storage should include a clean, dry environment to prevent contamination or damage. Standard EMS protocols for defibrillator maintenance (e.g., calibration, battery checks) should also be followed.