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Zoll E Series with See-Thru CPR

by Zoll Medical Corporation, World Wide Headquarters

510(k) K070455

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK070455 Date26 Apr 2007ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Zoll E Series with See-Thru CPR is an Automated External Defibrillator (Non-Wearable), designed to deliver defibrillation therapy and analyze cardiac rhythms during cardiopulmonary resuscitation (CPR). This device provides real-time ECG monitoring to assist rescuers in assessing rhythm quality and determining optimal pause times during CPR, enhancing resuscitation efforts. Its advanced technology integrates defibrillation with rhythm analysis to support effective emergency response in various clinical settings.

The Zoll E Series with See-Thru CPR is intended for use in pre-hospital and emergency medical services environments, where rapid and accurate defibrillation is critical. Supplied as a reusable medical device, it requires proper maintenance and calibration to ensure reliable performance. The device is classified as Class III under FDA regulations and holds a 510(k) clearance (K070455) for substantial equivalence. It is not intended for MRI use and must be stored in accordance with manufacturer guidelines to preserve functionality and sterility.

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