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Found 6 results
510(k) Data Aggregation
K Number
K053156Device Name
MINI-WRIGHT DIGITAL, MODEL 3120001
Manufacturer
CLEMENT CLARKE INTL., LTD.
Date Cleared
2006-01-31
(78 days)
Product Code
BZH
Regulation Number
868.1860Why did this record match?
Applicant Name (Manufacturer) :
CLEMENT CLARKE INTL., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mini-Wright Digital is a handheld, battery operated, electronic Peak Flow Meter and FEV1 monitoring device with an internal memory capable of storing 240 sets of readings. This product will be sold as an OTC device with appropriate instructions. When used to monitor conditions such as asthma, this device should be used under the direction of a physician or licensed health care professional. The device is intended for use with paediatric and adult patients in both home and clinical settings.
Device Description
The Mini-Wright Digital is a handheld, battery operated, electronic Peak Flow Meter and FEV I monitoring device with an internal memory capable of storing 240 sets of readings. This product will be sold as an OTC device with appropriate instructions.
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K Number
K042058Device Name
ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN
Manufacturer
CLEMENT CLARKE INTL., LTD.
Date Cleared
2005-03-23
(236 days)
Product Code
BZG
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
CLEMENT CLARKE INTL., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OneFlow FVC is a handheld, battery operated, electronic Spirometer intended to measure the maximal volume and flow of air that can be moved through a patient's lungs. The device is intended for use with pediatric and adult patients in a variety of clinical settings.
Additional models include the OneFlow FVC (kit), which contains software that can statistically analyze data on a PC; and the OneFlow FVC Screen, which displays the gathered data in comparison with stored predicted values.
Device Description
The OneFlow FVC is a handheld, battery operated, electronic spirometer. Additional models include the OneFlow FVC (kit), which contains software that can statistically analyze data on a PC; and the OneFlow FVC Screen, which displays the gathered data in comparison with stored predicted values.
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K Number
K000368Device Name
EYECAP IMAGING SYSTEM
Manufacturer
CLEMENT CLARKE INTL., LTD.
Date Cleared
2000-05-04
(90 days)
Product Code
HKI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
CLEMENT CLARKE INTL., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EyeCap Imaging System is used by Health Professionals to capture, store and manage output images from Retinal Cameras, Fundus Cameras and Video Slit Lamps.
Device Description
EyeCap Imaging System
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K Number
K982334Device Name
AIRZONE PEAK FLOWMETER
Manufacturer
CLEMENT CLARKE INTL., LTD.
Date Cleared
1999-01-14
(196 days)
Product Code
BZH
Regulation Number
868.1860Why did this record match?
Applicant Name (Manufacturer) :
CLEMENT CLARKE INTL., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AirZone Peak Flowmeter is intended to measure the peak expiratory flow rate for patients who have respiratory conditions such as Asthma, Emphysema or Reversible Airway Obstruction.
Device Description
AirZone Peak Flowmeter
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K Number
K980960Device Name
IN-CHECK INSPIRATORY FLOWMETER
Manufacturer
CLEMENT CLARKE INTL., LTD.
Date Cleared
1998-06-10
(86 days)
Product Code
BZH
Regulation Number
868.1860Why did this record match?
Applicant Name (Manufacturer) :
CLEMENT CLARKE INTL., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IN-CHECK is one of a family of simple devices used for monitoring respiratory conditions, and is suitable for use by the Health Care Professional or for home monitoring of nasal or oral inspiratory flow by the patient.
Some uses for the device are :-
1. Diagnosis of Nasal Obstruction
2. Assessment of Response to Nasal Provocation
3. Home Monitoring of PNIF
4. Oral Inspiratory Flow Measurement
Device Description
The IN-CHECK is one of a family of simple devices used for monitoring respiratory conditions.
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K Number
K962074Device Name
VM PLUS PEAK FLOWMETER
Manufacturer
CLEMENT CLARKE INTL., LTD.
Date Cleared
1997-01-02
(219 days)
Product Code
BZH
Regulation Number
868.1860Why did this record match?
Applicant Name (Manufacturer) :
CLEMENT CLARKE INTL., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
Not Found
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