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

System, Telethermographic, Infrared

21 CFR 884.2980 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

IYM is the FDA product code for System, Telethermographic, Infrared, a class III device type, regulated under 21 CFR 884.2980. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IYM
Device name
System, Telethermographic, Infrared
Regulation
21 CFR 884.2980
Device class
Class III
Review panel
Obstetrics/Gynecology
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code IYM

By decision year
8 clearances under product code IYM with a decision year between 1976 and 1986, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code IYM by decision year
YearClearances
19761
19802
19812
19821
19862

Applicants with the most clearances

Product code IYM
Applicants holding the most 510(k) clearances under product code IYM
ApplicantClearances
C.D. Regelin & Associates, Inc.1
Dorex, Inc.1
Flir Medical Systems1
Gst Laboratories of Ca, Inc.1
Honeywell, Inc.1
Hospital Financial Corp.1
Jeol1
Orthion 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 IYM.