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K Number
K960831

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Device Name
VENTRAK RMMS 1550
Manufacturer
NOVAMETRIX MEDICAL SYSTEMS, INC.
Date Cleared
1996-05-29

(90 days)

Product Code
BZC
Regulation Number
868.1880
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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§ 868.1880 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).