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K Number
K031397
Device Name
MERLIN E-MASK
Manufacturer
MERLIN MEDICAL LIMITED
Date Cleared
2004-07-29

(454 days)

Product Code
CBP
Regulation Number
868.5870
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Merlin Medical Limited Merlin E-Mask Air Pulmonary Resuscitator is indicated for mouth to mask ventilation of a non-breathing adult and child weighing over 30 kgs.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Merlin Medical Limited regarding their Merlin E-Mask. This document does not contain any information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for device performance. It only states that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory compliance requirements.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

§ 868.5870 Nonrebreathing valve.

(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).