510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QAFClass II

Impedance Plethysmograph, Cranial

21 CFR 870.2770 / Cardiovascular
FDA source (opens on fda.gov)

QAF is the FDA product code for Impedance Plethysmograph, Cranial, a class II device type, regulated under 21 CFR 870.2770. FDA's definition for this code reads: "Detect or measure variations in volume in the cranium, using tissue impedance properties". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QAF
Device name
Impedance Plethysmograph, Cranial
FDA definition
Detect or measure variations in volume in the cranium, using tissue impedance properties.
Regulation
21 CFR 870.2770
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
3
Ingested recalls
0

Clearances, product code QAF

By decision year
3 clearances under product code QAF with a decision year between 2017 and 2026, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QAF by decision year
YearClearances
20171
20181
20261

Applicants with the most clearances

Product code QAF
Applicants holding the most 510(k) clearances under product code QAF
ApplicantClearances
Cerebrotech Medical Systems2
Stroke DX1

Companies listing this code with FDA

Companies whose registered establishments list this code

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