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510(k) Data Aggregation
K Number
K090273Device Name
KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100
Manufacturer
KAI SENSORS, INC
Date Cleared
2009-06-05
(121 days)
Product Code
BZQ
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
KAI SENSORS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kai Sensors Non-Contact Respiratory Rate Spot Check Model 100 is intended for a one-time measurement of respiratory rate, as part of a vital signs assessment. The device is indicated for hospital or clinical use in adult patients. The device is intended to be operated by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.
The Kai Sensors Non-Contact Respiratory Rate Spot Check Model 100 is not intended to monitor vital signs. This device is not an apnea monitor.
Device Description
The Kai Sensors Non-Contact Respiratory Rate Spot Check Model 100 ("Kai RSpot 100") is a reusable sensor for measuring respiratory rate during vital sign spot checks. The Kai RSpot 100 uses a low-power radar to sense chest displacement in order to obtain a respiratory rate. When the hardware module is operating and facing a patient, the Doppler radar transmits a low-power radio-frequency signal and receives the signal after it has reflected off the patient's torso. The receiver detects a phase shift on the signal due to chest displacement and converts this phase shift into a voltage that is digitized and sent to the computer portable computer via USB. The portable computer runs the Kai RSpot 100 software, which determines a respiratory rate from the chest motion (respiratory effort) signal and provides the display, user interface, and power source for the device. The portable computer can operate on battery power or on wall power through outlets when used with the supplied power cord.
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