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K Number
K982487
Device Name
CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO
Manufacturer
CARDIOPULMONARY TECHNOLOGIES, INC.
Date Cleared
1998-10-14

(89 days)

Product Code
BZC
Regulation Number
868.1880
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Meteor is a handheld respiratory mechanics graphic monitor intended for use in the hospital clinical environment and transport, either land or air. It is intended for monitoring mechanically ventilated or supported pediatric and adult patients with tidal volumes greater than 100 ml. Meteor can be used for either continuous (Meteor 200) or spot check usage (Meteor 100 and 200). It is not intended to be used as an apnea monitor. No alarms are provided.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a respiratory mechanics monitor, but it does not detail the acceptance criteria, specific study design, or performance metrics of the device. It primarily discusses regulatory aspects and allows the device to be marketed.

§ 868.1880 Pulmonary-function data calculator.

(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).