CARDIO SERV— 510(k) K951110

Name: FDA 510(k) clearance K951110
Creator: U.S. Food and Drug Administration
Published: 1995-09-15

Substantially Equivalent

Hellige GmbH

FDA 510(k) clearance K951110 for CARDIO SERV, Substantially Equivalent on 1995-09-15. Applicant: Hellige GmbH. Device class: 2.

Clearance details

Applicant: Hellige GmbH
Product code: Code LDD
Device class: Class 2
Regulation: 21 CFR 870.5300
Advisory panel: Cardiovascular
Date received: 1995-03-10
Decision date: 1995-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: D7800 Freiburg Im Breisga, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code LDD

view all

K203231 — Switched Internal Paddles2021-01-11
K200849 — Tempus LS - Manual2020-07-24
K182503 — Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors2019-06-03
K150349 — Rapid Hair Removal Pads2015-07-14
K140502 — ZOLL E SERIES ALS2014-11-06

More clearances from Hellige GmbH

view all

K950989 — CARDIOSMART1996-05-13

Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.