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

Cranial Sound Monitor

21 CFR 870.1875 / Cardiovascular
FDA source (opens on fda.gov)

QBE is the FDA product code for Cranial Sound Monitor, a class II device type, regulated under 21 CFR 870.1875. FDA's definition for this code reads: "To non-invasively detect, monitor, record and display acoustic signals in the brain". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QBE
Device name
Cranial Sound Monitor
FDA definition
To non-invasively detect, monitor, record and display acoustic signals in the brain.
Regulation
21 CFR 870.1875
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QBE

By decision year
1 clearance under product code QBE with a decision year between 2018 and 2018, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QBE by decision year
YearClearances
20181

Applicants with the most clearances

Product code QBE
Applicants holding the most 510(k) clearances under product code QBE
ApplicantClearances
Headsense Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QBE.