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

System, Telethermographic (Adjunctive Use)

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

LHQ is the FDA product code for System, Telethermographic (Adjunctive Use), a class I device type, regulated under 21 CFR 884.2980. As of , FDA records hold 41 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LHQ
Device name
System, Telethermographic (Adjunctive Use)
Regulation
21 CFR 884.2980
Device class
Class I
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
41
Ingested recalls
1

Clearances, product code LHQ

By decision year
41 clearances under product code LHQ with a decision year between 1984 and 2026, 1985 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LHQ by decision year
YearClearances
19841
19854
19861
19871
19902
19951
19971
19982
19991
20013
20022
20034
20042
20062
20081
20111
20121
20151
20161
20172
20191
20212
20222
20231
20261

Applicants with the most clearances

Product code LHQ
Applicants holding the most 510(k) clearances under product code LHQ
ApplicantClearances
Bales Scientific, Inc.2
First Sense Medical, LLC2
Micro Health Systems, Inc.2
Thermatrek2
USA Therm Inc.2
Ag Digital Technology Corp.1
Alfa Thermodiagnostics, Inc.1
Clearwater Computer Center, Inc.1
Dorex, Inc.1
Em Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order