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510(k) Data Aggregation
K Number
K133722Device Name
ASTHMA MONITOR AM3
Manufacturer
ERESEARCH TECHNOLOGY
Date Cleared
2014-05-08
(154 days)
Product Code
BZG
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
ERESEARCH TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Asthma Monitor AM3/AM3 GSM is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever there is a need of. The AM3 measures the flow during expiration serving for the calculation of further parameters as FEV1.
The AM3 is used to monitor the respiratory status of adult human beings in the areas of asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management.
The patient is informed of the results by numeric values for the selected parameters (e.g. PEF, FEV1). Furthermore, a visual control unit, displayed in the form of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician.
The device saves the results of a measurement (always with date and time) automatically in an internal database. In addition, questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life" status. When enabled, the AM3 can be programmed with a couple of questions, where the patient can then select from a couple of different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS.
The AM3 is designed to replace an ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM3 to be used in healthcare, clinical and home use environments/settings.
Device Description
The Asthma Monitor AM3 GSM is a medical device (peak flow meter with symptom diary) providing following characteristics:
- Handheld device
- Battery operation
- Storing capacity of 1200 measurements
- Storing capacity of 400 sets of questionnaires (max. 20 questions each)
- Measurement Parameters: PEF and FEV1
- Accuracy Flow: ± 5% or ± 20 1/min
- Accuracy Volume: ± 3% or ± 0.05 liter
- Data transmission to computer/database via USB, Bluetooth, GSM and Serial (RS232)
- Flow sensor (single patient use)
- Mouthpiece (single patient use)
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