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

Cerebral Oximeter

21 CFR 870.2700 / Cardiovascular
FDA source (opens on fda.gov)

QEM is the FDA product code for Cerebral Oximeter, a class II device type, regulated under 21 CFR 870.2700. FDA's definition for this code reads: "Oximeter to measure cerebral tissue saturation". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QEM
Device name
Cerebral Oximeter
FDA definition
Oximeter to measure cerebral tissue saturation
Regulation
21 CFR 870.2700
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 QEM

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

Applicants with the most clearances

Product code QEM
Applicants holding the most 510(k) clearances under product code QEM
ApplicantClearances
Mespere Lifesciences Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order