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510(k) Data Aggregation
K Number
K120880Device Name
ORBIT
Manufacturer
Date Cleared
2012-04-19
(27 days)
Product Code
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
NATIONAL BIOMEDICAL LLC DBA QRS DIAGNOSTIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- Device Functionality: Spirometry .
- Primary Spirometric Parameters: FVC, MVV, SVC and FEF .
- Patient Population: Male/Female, Pediatric to Adult .
- Environment of Use: Hospital, Clinic and Home Use under trained professional supervision (Prescription Use)
The QRS Diagnostic Orbit Spirometer is intended for the acquisition, analysis, display and print of measurements and waveforms of pulmonary function for the purposes of assily any clinicians in the diagnosis of various pulmonary function diseases and/or treatment regimens.
Device Description
The QRS Orbit product model Z-7000-0101 consisting of a spirometer, pressure tube, disposable pneumotachometer, Office Medic Software and a host computer is a compact and versatile personal computer (PC) based pulmonary function analyzer (spirometer). The product measures a patient's expiratory and inspiratory airflow, analyzes the data with print options that includes the measured and predicted values and flow vs. volume or volume vs. time graphs.
The Orbit spirometer includes the following components:
- . Spirometer
- Spirometer Pressure Tube .
- Disposable pneumotachometer (mouthpiece)
- Office Medic Software .
- Host PC (User Provided) .
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