510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QTVClass I

Mattress And Bed Deck Cover (Medical Purposes)

21 CFR 880.6190 / General Hospital
FDA source (opens on fda.gov)

QTV is the FDA product code for Mattress And Bed Deck Cover (Medical Purposes), a class I device type, regulated under 21 CFR 880.6190. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QTV
Device name
Mattress And Bed Deck Cover (Medical Purposes)
FDA 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.
Regulation
21 CFR 880.6190
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QTV

By decision year
1 clearance under product code QTV with a decision year between 2022 and 2022, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QTV by decision year
YearClearances
20221

Applicants with the most clearances

Product code QTV
Applicants holding the most 510(k) clearances under product code QTV
ApplicantClearances
Trinity Guardion, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code