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510(k) Data Aggregation
K Number
K072722Device Name
MEDDORNA WIRELESS PRN SPIROMETER 100
Manufacturer
Date Cleared
2008-04-24
(211 days)
Product Code
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
MEDDORNA LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MEDDORNA Wireless PRN Spirometer Model 100 is intended for use as a diagnostic spirometer, measuring FVC, MVV and SVC breathing functions.
Device Description
The MEDDORNA Wireless PRN Spirometer 100 is a full featured spirometer allowing Forced Vital Capacity (FVC) spirometry, Maximum Voluntary Ventilation (MVV), and Slow Vital Capacity (SVC) and all spirometry tests will be available, including pre/post bronchodilator testing.
The MEDDORNA Wireless PRN Spirometer 100 utilizes wireless interface to a thin client Personal Computer or Internet Server. This allows real-time graphical display and review of the spirometry loop along with alpha character patient entry when desired.
The MEDDORNA Wireless PRN Spirometer 100 utilizes pre-calibrated plastic disposable mouthpieces; this negates the need for a 3-liter syringe. The MEDDORNA Wireless PRN Spirometer has a rechargeable battery pack and wireless (Bluetooth) data link output directly to a thin client PC for reporting purposes.
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