Devices · Medasense Biometrics Ltd.

PMD-200

Medasense Biometrics Ltd. is listed for PMD-200 (DEN210022). The FDA list gives February 17, 2023 as the date of the final decision. The lead panel is Anesthesiology, and the database link on the FDA list is the De Novo pathway. openFDA describes product code QVE as “Adjunctive Pain Measurement Device For Anesthesiology”: An adjunctive pain measurement device for anesthesiology is a prescription device that includes software algorithms to analyze physiological sensor data and measure response to painful stimuli in patients under general anesthesia. The device may be software-only or it may include hardware such as physiological sensors. This device type is intended for adjunctive use to tailor analgesic administration to a patient’s actual response to painful stimuli and is not intended to independently direct decision-making. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210022

Official FDA database record

Date of final decision

February 17, 2023

Company on the FDA list

Medasense Biometrics Ltd.

Lead panel

Anesthesiology

Primary product code

QVE

openFDA device name for the code

Adjunctive Pain Measurement Device For Anesthesiology

Device class

2

Regulation number

868.2200

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned