Search Results
Found 1 results
510(k) Data Aggregation
K Number
K100773Device Name
KAI SPOT MODEL KMS 200
Manufacturer
Date Cleared
2010-06-23
(97 days)
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
KAI MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Kai Medical Non-Contact Respiratory Rate Spot Check Model KMS 200 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 Medical Non-Contact Respiratory Rate Spot Check Model KMS 200 is not intended to monitor vital signs. This device is not an apnea monitor
Device Description
The sensor includes a 2.4 GHz Doppler radar, data acquisition circuitry, processing, user interface, and touch-screen display. The touch-screen display provides the display and user interface. The device is powered over the USB connection, either by a PC, with a wall-power adapter, or with an external battery. If desired, the Kai Spot KMS 200 has the capability to communicate via its USB interface with a personal computer (PC) using select Kai Spot data management software applications. The sensor uses Doppler radar to detect respiratory effort, and the respiratory effort signal is analyzed to provide a respiratory rate. A radio wave in the 2.4 GHz ISM band is emitted from the antenna included in the hardware module. The Kai Spot KMS 200 sensor enclosure includes screw holes in a VESA mounting pattern (VESA is a standard mounting configuration), which can be used to connect to any VESA mount, including stands, carts, wall-mounts, or adapters to other stands or carts. A stand is not included with the device; the customer's Biomedical Engineering Department or maintenance service should install the device on a medical-grade stand used for vital signs measurement equipment. Screws to be used for mounting are provided with the device.
Ask a Question
Ask a specific question about this device
Page 1 of 1