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510(k) Data Aggregation
K Number
K141793Device Name
PULMONE MINIBOXPFT 2.0
Manufacturer
PULMONE ADVANCED MEDICAL DEVICES, LTD.
Date Cleared
2015-03-06
(247 days)
Product Code
BZG, BZC
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
PULMONE ADVANCED MEDICAL DEVICES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PulmOne MiniBoxPFT™ 2.0 is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT™ 2.0 is to be used by either a physician, respiratory therapist, or technician.
Device Description
The PulmOne MiniBoxPFT™ 2.0 is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT™ 2.0 is to be used by either a physician, respiratory therapist, or technician. A single-use, disposable viral-bacterial filter separates the patient from the internal components of the device.
The MiniBoxPFT™ 2.0 measures all common spirometric measurements as well as relative and absolute lung volumes, including the following (the full list is detailed in Section 11 - Device Description):
Absolute Lung Volumes:
Total lung capacity (TLC) L
Thoracic Gas Volume (TGV) L
Residual volume (RV) L
Relative Lung Volumes:
Inspiratory capacity (IC) L
Expiratory reserve volume (ERV) L
Spirometry:
Forced vital capacity (FVC) L
Forced inspiratory vital capacity (FIVC) L
Slow vital capacity (SVC) L
Slow inspiratory vital capacity (IVC) L
Forced expiratory volume in 1 second (FEV1) L
Forced inspiratory volume in 1 second (FIV1) L
Ratio of FEV1 to SVC (FEV1/SVC) %
Ratio of FEV1 to FVC (FEV1/FVC) %
Forced expiratory volume in 6 seconds (FEV6) L
Ratio of FEV1 to FEV6 (FEV1/FEV6) %
Peak expiratory flow (PEF) L/s
Peak inspiratory flow (PIF) L/s
Forced Expiratory Flow at 50% of FVC (FEF50) L/s
Maximum Voluntary Ventilation (MVV) L/min
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