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K Number
K961077
Device Name
PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE
Manufacturer
HEALTHSCAN PRODUCTS, INC.
Date Cleared
1996-07-15

(119 days)

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

§ 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).