← FDA Medical Device Classifications

System, Telethermographic (Adjunctive Use)

LHQ · Class I — Low Risk (general controls) · Obstetrics/Gynecology · 21 CFR 884.2980

Classification

FDA Product Code
LHQ
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 884.2980
Review panel
RA
Medical specialty
Obstetrics/Gynecology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
40
Registered establishments
12

Source

Authoritative
FDA Device Classification database
Machine
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