# K020280: Pulmolab EX671 Exercise Testing System

- Pathway: 510(k) (Traditional)
- Applicant: Morgan Medical, Ltd.
- Decided: Sep 24, 2002 after 239 days
- Product code: BZG (Spirometer, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 868.1840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Morgan EX 67 I 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 And from the directly 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

Source page: https://510kreport.com/device/K020280
Methodology: https://510kreport.com/methodology