(112 days)
The MD300A/MD300K2/MD300M handheld pulse oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult and pediatric patients in hospitals and home care.
Handheld Pulse Oximeter Model MD300A/ MD300K2/ MD300M
This document is a 510(k) premarket notification letter for a Handheld Pulse Oximeter and does not contain the detailed study information required to fill out the table and answer all the questions. The letter confirms that the device is substantially equivalent to legally marketed predicate devices but does not include the actual performance data, acceptance criteria, or study design details.
Therefore, I cannot provide the requested information from the given text. The relevant sections like "Acceptance criteria and the study that proves the device meets the acceptance criteria" are not present.
The document only states the "Regulation Number: 21 CFR 870.2700" and "Regulation Name: Oscillometer" which would generally dictate the standards and required performance for such a device, but the specific acceptance criteria and study proving compliance are not detailed here.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).