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K Number
K984468
Device Name
VITAL PEP
Manufacturer
VITAL SIGNS, INC.
Date Cleared
1999-06-01

(167 days)

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

The Vital PEP™ positive expiratory pressure device indicated for facilitating the opening of airways in patients suffering from COPD , Cystic Fibrosis, Asthma and other diseases with ... coretory groblems.

Device Description

Vital PEP™ positive expiratory pressure device

AI/ML Overview

The provided text is a 510(k) clearance letter for the Vital PEP™ device and does not contain information about acceptance criteria or a study proving the device meets them.

Therefore, I cannot answer your request based on the provided input. This document simply states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices and can proceed to market. It does not include performance data, study designs, or ground truth establishment details.

§ 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).