A reference standard device intended to represent one end of a medical quick-connect coupling or a terminal unit of a gas-specific format [e.g., oxygen (O2), nitrous oxide (N2O), medical air], which may be used to evaluate connection port compatibility and ...
An electroacoustic device intended to be used for the evaluation of hearing loss (audiometer function), the evaluation of hearing aids while worn to assure optimal amplification (real-ear measurement), and/or for other hearing aid analysis (functions as the...
An electroacoustic device intended to be used for both the evaluation of hearing loss (audiometer function) and the evaluation of hearing aids while worn for optimal amplification [real-ear measurement (REM)]; some types may in addition be used to test hear...
A collection of portable devices intended to imitate a variety of physiological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, and haemoglobin oxygen saturation (SpO2)] and conditions in order to test ...
An electrically-powered device intended to be used for the uniform heating of the contents of a microplate, test tube, and/or assay/reagent/test card, as part of an incubation step required during the in vitro diagnostic processing of a clinical specimen. I...
A device assembly designed to assess the performance of infusion pumps by accurately measuring, evaluating, displaying, and/or recording a set of pump variables (typically output flow, volume delivery, and occlusion pressure needed to activate the pump alar...
An assembly of battery-powered devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function ...
An assembly of mains electricity (AC-powered) devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficien...
A mains electricity (AC-powered) device intended to be used for sealing packaged products and utensils, e.g., blood products, test tubes or sterilized instruments/equipment, through the application of heat upon the packaging materials to create an airtight ...
An electrically-powered device designed to measure the stability of a dental implant by creating a noninvasive vibrational force and subsequently detecting the amount of movement in the implant [typically referred to as resonance frequency analysis (RFA)]. ...
An electrically-powered device designed to measure the stability of a dental implant by creating a noninvasive vibrational force and subsequently detecting the amount of movement in the implant. It is used with a disposable peg (not included) inserted into ...
An ophthalmic device for binocular vision testing. The patient views a four-dot light combination (1 white, 1 red and 2 green) through coloured glasses and informs the examining doctor when the combination perceived changes. This visual impression provides ...
A collection of devices intended to be used to test/calibrate a clinical heater/cooler system (e.g., extravascular-circulation hyperthermia system, heating/cooling pad systems) with respect to fluid flow, thermal calibration, and electronic integrity. The k...
A portable electronic device designed to: 1) remotely control an electronic ambulatory insulin infusion pump; and 2) measure blood glucose levels to aid a diabetes mellitus patient in self-management of insulin therapy. It consists of a wireless unit that i...
An electrically-powered device intended to be used to control one or multiple in vitro diagnostic laboratory analyser(s)/instrument(s) used in the processing/preparation/analysis of a clinical specimen. It is designed to enable the user to input/manipulate ...
An electrically-powered device designed to test the quality of a battery's recharging abilities in order to assess its value for continued use. The unit may have a built-in charging function.
A portable, electrically-powered device intended to be used to receive and display results and/or errors from an assay performed on an immunoassay reagent vehicle (e.g., test strip, cassette, cartridge, or card). It is a rechargeable unit with multiple slot...
An electrically-powered device intended to be used exclusively at the point-of-care by medical professionals to spot-check measure and record multiple physiological and biological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure and hae...
An electrically-powered unit intended to produce electrical signals for preoperative and/or intraoperative application of electrical stimulation, via a connected hand-held probe with distal electrodes (not included), to a neural tissue site to: 1) locate ne...