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Innolitics
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Review Panel
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Review Panel
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Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
IYM
System, Telethermographic, Infrared
3
Product Code
K
86
3736
FMS MODEL 110
3
Cleared 510(K)
K
85
2950
VISITHERM
3
Cleared 510(K)
K
82
3041
JEOL MODEL #JTG-500M
3
Cleared 510(K)
K
81
2799
DCATS
3
Cleared 510(K)
K
81
2701
ORTHO-THERM INFRARED SENSOR
3
Cleared 510(K)
K
80
1553
THERMOCOMP
3
Cleared 510(K)
K
80
0491
GRAPHIC STRESS TELETHERMOMETRY
3
Cleared 510(K)
K
76
0999
THERMOGRAPH, MEDICAL
3
Cleared 510(K)
KXZ
System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
3
Product Code
KYA
System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)
1
Product Code
LHM
System, Thermographic, Liquid Crystal
1
Product Code
LHP
System, Telethermographic (Sole Diagnostic Screen)
3
Product Code
LHQ
System, Telethermographic (Adjunctive Use)
1
Product Code
LHR
System, Thermographic, Liquid Crystal (Sole Diagnostic Screen)
3
Product Code
LXE
Doppler, Fetal, Ultrasound
2
Product Code
MAA
Monitor, Fetal Doppler Ultrasound
2
Product Code
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 9 May 2025 at 11:05 pm
RA
/
subpart-c—obstetrical-and-gynecological-monitoring-devices
/
IYM
/
K863736
View Source
FMS MODEL 110
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K863736
510(k) Type
Traditional
Applicant
FLIR MEDICAL SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent for Some Indications
Decision Date
12/29/1986
Days to Decision
97 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
IYM
System, Telethermographic, Infrared
K
86
3736
FMS MODEL 110
K
85
2950
VISITHERM
K
82
3041
JEOL MODEL #JTG-500M
K
81
2799
DCATS
K
81
2701
ORTHO-THERM INFRARED SENSOR
K
80
1553
THERMOCOMP
K
80
0491
GRAPHIC STRESS TELETHERMOMETRY
K
76
0999
THERMOGRAPH, MEDICAL
KXZ
System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
KYA
System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)
LHM
System, Thermographic, Liquid Crystal
LHP
System, Telethermographic (Sole Diagnostic Screen)
LHQ
System, Telethermographic (Adjunctive Use)
LHR
System, Thermographic, Liquid Crystal (Sole Diagnostic Screen)
LXE
Doppler, Fetal, Ultrasound
MAA
Monitor, Fetal Doppler Ultrasound
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous Devices
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
RA
/
subpart-c—obstetrical-and-gynecological-monitoring-devices
/
IYM
/
K863736
View Source
FMS MODEL 110
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K863736
510(k) Type
Traditional
Applicant
FLIR MEDICAL SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent for Some Indications
Decision Date
12/29/1986
Days to Decision
97 days