Mattress And Bed Deck Cover (Medical Purposes)

QTV · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.6190

Classification

FDA Product Code: QTV
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 880.6190
Review panel: HO
Medical specialty: General Hospital
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A mattress and bed deck cover for medical purposes is intended to provide a physical barrier between the patient and the mattress as well as all or parts of the bed deck or frame.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 9

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown