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Cardio Serv

by Hellige GmbH

510(k) K951110

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 · Traditional NumberK951110 Date15 Sep 1995ClearedStatusActive

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  • Withdrawn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
LDD
Device Class
Class II
Regulation
21 CFR Part 870.5300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 CardioServ Defibrillator is a medical device designed for the delivery of low-energy defibrillation therapy, including paddles, as classified under device class 2. It is intended for use in emergency cardiovascular situations, such as cardiac arrest, to restore normal heart rhythm.

The device is supplied as a single-use or reusable unit, depending on the model, and is not MRI safe. It requires proper storage and handling according to manufacturer guidelines. The CardioServ Defibrillator is authorized under FDA 510(k) clearance, with a K number of K951110, and is classified under product code LDD.

Questions

AI-generated answers, 26 Sep 2026

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

  • What is the CardioServ Defibrillator used for?

    This device is intended for emergency cardiovascular situations, such as cardiac arrest, to deliver low-energy defibrillation therapy and restore normal heart rhythm.

  • Is the CardioServ Defibrillator reusable or single-use?

    The device is supplied as a single-use or reusable unit, depending on the specific model.

  • Is the CardioServ Defibrillator MRI safe?

    No, the CardioServ Defibrillator is not MRI safe.

  • What is the regulatory status of the CardioServ Defibrillator?

    The CardioServ Defibrillator is authorized under FDA 510(k) clearance, with a K number of K951110.