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510(k) Data Aggregation
K Number
K161676Device Name
Q13 SPIROLYSER®
Manufacturer
FIM MEDICAL
Date Cleared
2016-10-20
(125 days)
Product Code
BZG
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
FIM MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to perform spirometry in hospital and clinical environments, for adult patients and pediative patients aged 6 years and above.
Device Description
The SPIROLYSER® Q13 is an electronic spirometer operating on a PC, for the exploration of respiratory function. The spirometer is composed of a single-use sensor that propels the air (FLEISCH principle) and obtains a difference in pressure. Definition of Fleisch type pneumotachograph: A pneumotachograph that measures flow in terms of the proportional pressure drop across a resistance consisting of numerous capillary tubes in parallel. The SPIROWIN® EXPERT software acquires samples sent by the spirometer and determines a flow and a volume so as to display the curves and deduce results. The SPIROLYSER® 013 spirometer is a portable device. In normal use, the patient holds it by the handle, placing the single-use sensor in the mouth. The SPIROLYSER® Q13 is directly powered by the computer USB port via its USB lead. The SPIROWIN® EXPERT software (on the attached PC) calculates, displays and stores data to help the practitioner in the exploration of a patient's respiratory function.
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K Number
K080278Device Name
TABATABA COTESTER
Manufacturer
FIM MEDICAL
Date Cleared
2008-11-28
(298 days)
Product Code
CCJ
Regulation Number
868.1430Why did this record match?
Applicant Name (Manufacturer) :
FIM MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TABATABA® CO TESTER is for the monitoring of Carbon Monoxide in exhaled breath. It is for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It can also be used for ambient air monitoring. It is for use by health professionals.
Device Description
The TABATABA is a battery operated hand held carbon monoxide monitor for use as an aid in smoking cessation programs. The TABATABA is a complete tool for the prevention of the risks of active or passive smoking. It can be carried in the pocket or on the belt. The device is parametered by an internal menu (time, date, alarm threshold, measurement time of monitoring). It can be connected to a computer via an RS232 port, to record and analyze results.
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K Number
K050424Device Name
ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50
Manufacturer
FIM MEDICAL
Date Cleared
2005-06-23
(125 days)
Product Code
BZG
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
FIM MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to perform spirometry and may be used in hospitals and medical offices or at other locations including homes. The accessory is a Bacterial/Viral Filter designed for single patient use. For use on both adult and pediatric patients.
Device Description
The Ergofilter™ SP1 filter is a bacterial and viral filter with an anatomical mouthpiece, for spirometers. The filter is a single use, non-sterile filter. A new filter must be used for each new patient and for each new spirometry examination. Operating principle of Filtrete™ 3M™ filtration medium: The filtering medium is manufactured by the 3M company in a clean room; it uses an electrostatic process which attracts small mass particles, while having a very small resistance to arr flow; the density and thickness of the filtration medium itself provides an increased filtration capacity.
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K Number
K010761Device Name
SPL-50 SPIROLYSER
Manufacturer
FIM MEDICAL
Date Cleared
2002-03-05
(357 days)
Product Code
BZG
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
FIM MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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