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510(k) Data Aggregation
K Number
K200832Device Name
Safey Peak Flow Meter
Manufacturer
Safey Medical Devices Pvt Ltd
Date Cleared
2020-07-30
(122 days)
Product Code
BZH
Regulation Number
868.1860Why did this record match?
Applicant Name (Manufacturer) :
Safey Medical Devices Pvt Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Safey Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment.
The device is designed for children greater than five years of age, adolescent and adult subjects.
Device Description
Safey Peak Flow Meter is an over-the-counter medical device to help respiratory patients keep track of their lung health. This device measures Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1). Safey Peak Flow Meter is a pocket device intended for home use and operates on two AAA type standard alkaline batteries.
Safey Peak Flow Meter works on infrared interrupt concept. The turbine consists of a vane which rotates clockwise or anti-clockwise depending on the direction of flow into the turbine. The device consists of Infrared pairs which detects the direction and speed of rotation of the vane, which is further calculated to PEF and FEV1. The device connects with a Medical Mobile Application (Safey App) using BLE (Bluetooth Low Energy) to display the test results to the User.
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K Number
K201002Device Name
Safey Pocket Spirometer
Manufacturer
Safey Medical Devices Pvt Ltd
Date Cleared
2020-07-30
(105 days)
Product Code
BZG
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
Safey Medical Devices Pvt Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Safey Pocket Spirometer is a spirometer intended to be used by a patient under the instruction of a physician to perform basic lung function and spirometry testing for users above 5 years of age in home healthcare environment.
Device Description
Safey Pocket Spirometer is a prescription use medical device to help respiratory patients keep track of their lung health. This device is a portable spirometer intended for above 5 years of age. Safey Pocket Spirometer is a pocket device intended for home use and operates on two AAA type standard alkaline batteries. Safey Pocket Spirometer works on infrared interrupt concept. The turbine consists of a vane which rotates clockwise or anti-clockwise depending on the direction of flow into the turbine. The device consists of Infrared pairs which detects the direction and speed of rotation of the vane, which is further calculated to interpretable spirometry values. The device connects with a Medical Mobile Application (Safey App) using BLE (Bluetooth Low Energy) to display the test results to the User.
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