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

Synchronizer, Ecg / Respirator, Radiographic

21 CFR 892.1970 / Radiology
FDA source (opens on fda.gov)

IXO is the FDA product code for Synchronizer, Ecg / Respirator, Radiographic, a class I device type, regulated under 21 CFR 892.1970. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IXO
Device name
Synchronizer, Ecg / Respirator, Radiographic
Regulation
21 CFR 892.1970
Device class
Class I
Review panel
Radiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code IXO

By decision year
4 clearances under product code IXO with a decision year between 1980 and 1986, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code IXO by decision year
YearClearances
19801
19812
19861

Applicants with the most clearances

Product code IXO
Applicants holding the most 510(k) clearances under product code IXO
ApplicantClearances
Brattle Instrument Corp.1
Medrad, Inc.1
Radiation Measurements, Inc.1
Siemens Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code