JED · Class III — High Risk (PMA approval required, life-sustaining) · Anesthesiology · 21 CFR 868.1120
Classification
FDA Product Code
JED
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 868.1120
Review panel
AN
Medical specialty
Anesthesiology
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.