FDA 510(k)

Reusable Silicone Cover CPRmeter 2

K-Number: K183348 · 2018-12-17

Decision Date2018-12-17

Product CodeLIX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Reusable Silicone Cover CPRmeter 2 is the device name listed in this FDA 510(k) record. The listed applicant is Laerdal Medical AS. It received FDA 510(k) clearance on 2018-12-17 under 510(k) number K183348. The device is classified under product code LIX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reusable Silicone Cover CPRmeter 2?

Reusable Silicone Cover CPRmeter 2 is a medical device that received FDA 510(k) clearance on 2018-12-17. The listed applicant is Laerdal Medical AS. The 510(k) number is K183348.

When did Reusable Silicone Cover CPRmeter 2 receive FDA 510(k) clearance?

Reusable Silicone Cover CPRmeter 2 received FDA 510(k) clearance on 2018-12-17, under 510(k) number K183348.

Who is the listed applicant for Reusable Silicone Cover CPRmeter 2?

The FDA 510(k) record lists Laerdal Medical AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reusable Silicone Cover CPRmeter 2?

The FDA product code for Reusable Silicone Cover CPRmeter 2 is LIX.

Other records listing Laerdal Medical AS as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251631The BAG manual resuscitator and accessories K232111NeoBeat, NeoBeat Mini K173886CPRmeter 2 CPR Feedback Device

Related Devices (Code: LIX)

K201581CPR BANDCredo K173886CPRmeter 2 CPR Feedback DeviceLaerdal Medical AS

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.