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

Block, Test, Ultrasonic Scanner Calibration

21 CFR 882.1925 / Neurology
FDA source (opens on fda.gov)

GXX is the FDA product code for Block, Test, Ultrasonic Scanner Calibration, a class I device type, regulated under 21 CFR 882.1925. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GXX
Device name
Block, Test, Ultrasonic Scanner Calibration
Regulation
21 CFR 882.1925
Device class
Class I
Review panel
Neurology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code GXX

By decision year
3 clearances under product code GXX with a decision year between 1985 and 1989, 1985 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GXX by decision year
YearClearances
19852
19891

Applicants with the most clearances

Product code GXX
Applicants holding the most 510(k) clearances under product code GXX
ApplicantClearances
Echo Ultrasound1
Radiation Measurements, Inc.1
Technicare Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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