PCM · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.5050
Classification
FDA Product Code
PCM
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 890.5050
Review panel
AN
Medical specialty
Physical Medicine
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
To assist the user with refilling a portable liquid oxygen tank from a reservoir unit by holding the portable liquid oxygen tank in an upright position.