LogoFDA 510(k) Search
K Number
K960831
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
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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).