JED

Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

Product code

JED

Device name

Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

Device class

Class 3

21 CFR

21 CFR 868.1120

Medical specialty

Anesthesiology

Marketing pathway

PMA

FDA classification definition

A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to an indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976. Any other indwelling blood oxyhemoglobin concentration analyzer shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

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