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510(k) Data Aggregation
K Number
K020280Device Name
PULMOLAB EX671 EXERCISE TESTING SYSTEM
Manufacturer
Date Cleared
2002-09-24
(239 days)
Product Code
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
MORGAN MEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Morgan EX 671 exercise test system is intended as a configurable, non-invasive exercise testing system, targeted at a population age range of between 5 and 85 and capable of measuring directly the following parameters:
a. Tidal volume
b. Breathing frequency
c. Expired oxygen
d. Expired carbon dioxide
Based on the measured parameters the instrument calculates the following parameters:
a. Oxygen uptake
b. Carbon dioxide production
c. Ventilation
d. Respiratory exchange ratio
e. Time of inspiration
f. Time of expiration
g. End tidal oxygen
h. End tidal carbon dioxide
i. Anaerobic threshold
Device Description
The Morgan EX 671 exercise test system is intended as a configurable, non-invasive exercise testing system.
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