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K Number
K022636
Device Name
BODY BOX 5500
Manufacturer
MORGAN SCIENTIFIC, INC.
Date Cleared
2003-01-13

(158 days)

Product Code
JEH
Regulation Number
868.1760
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Body Box 5500 when used in conjunction with a computer and the ComPAS pulmonary function software is intended to perform plethysmography, diffusion and spirometry to provide pulmonary function testing in adult and pediatric patients.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the "Body Box 5500" device. It does not contain the specific information needed to answer the request about acceptance criteria and a study proving a device meets them. The letter confirms substantial equivalence to a predicate device but does not detail performance metrics, study design, or results.

Therefore, I cannot provide the requested information based on the provided text.

§ 868.1760 Volume plethysmograph.

(a)
Identification. A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes.(b)
Classification. Class II (performance standards).