← FDA Medical Device Classifications

Patient Bed With Canopy/Restraints

OYS · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.6760

Classification

FDA Product Code
OYS
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 880.6760
Review panel
HO
Medical specialty
General Hospital
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

Enclosed bed canopy system used as passive restraint.

Market data

Cleared 510(k) submissions
3
Registered establishments
11

Source

Authoritative
FDA Device Classification database
Machine
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