OUG

Medical Device Data System

Product code

OUG

Device name

Medical Device Data System

Device class

Class 1

21 CFR

21 CFR 880.6310

Medical specialty

General Hospital

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) the electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring.

Definition text from the FDA device classification database (U.S. federal government work, public domain).