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K Number
K953055

Validate with FDA (Live)

Device Name
MISTASSIST BREATHING EXERCISER
Manufacturer
THE MERLIN CORP.
Date Cleared
1996-02-08

(223 days)

Product Code
BWF
Regulation Number
868.5690
Type
Traditional
Panel
Anesthesiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 868.5690 Incentive spirometer.

(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).