Reusable Silicone Cover CPRmeter 2— 510(k) K183348

Name: FDA 510(k) clearance K183348
Creator: U.S. Food and Drug Administration
Published: 2018-12-17

Substantially Equivalent

Laerdal Medical AS

FDA 510(k) clearance K183348 for Reusable Silicone Cover CPRmeter 2, Substantially Equivalent on 2018-12-17. Applicant: Laerdal Medical AS. Device class: 2.

Clearance details

Applicant: Laerdal Medical AS
Product code: Code LIX
Device class: Class 2
Regulation: 21 CFR 870.5210
Advisory panel: Cardiovascular
Date received: 2018-12-03
Decision date: 2018-12-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Stavanger, NO

Download summary PDF View on FDA.gov ↗

Recent devices under product code LIX

view all

K201581 — CPR BAND2021-03-06
K173886 — CPRmeter 2 CPR Feedback Device2018-03-23
K151702 — Reusable Full Silicone Cover2015-08-13
K123248 — CPR RSQ ASSIST2013-12-10
K123597 — TRUECPR COACHING DEVICE2013-04-17

More clearances from Laerdal Medical AS

view all

K251631 — The BAG manual resuscitator and accessories2025-11-24
K232111 — NeoBeat, NeoBeat Mini2024-06-25

Adverse events under product code LIX

product code LIX

Other: 2
Total: 2

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.