510(k) clearances

Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)

Shenzhen Finicare Co., Ltd. · General Hospital

K243136Substantially EquivalentTraditionalFLL
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
General Hospital
Address 1
201, #50, The 3rd Industrial Park, Houting Community,
Address 2
Shajing St., Bao'An District
Statement or summary
Summary
Product code
FLL
Zip code
518104
Applicant
Shenzhen Finicare Co., Ltd.
Decision date
2025-02-14
Decision code
SESE
Country code
CN
Device name
Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)
Advisory committee
HO
Contact
Li Chao
K number
K243136
Date received
2024-09-30
Review advisory committee
HO
Postal code
518104
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Continuous Measurement Thermometer
Medical specialty description
General Hospital
Regulation number
880.2910
Device class
2
Registration number
3006852457, 2648045, 8043323, 3003965134, 3008729547, 3008167616, 3003589956, 3012302888, 3013019728, 3038295706, 1314417, 3017896172, 3015768317, 3010390468, 3004111573, 3016674095, 3027285900, 3043226252, 3014541700, 3009156722, 3024512705, 3043513123, 3003622639, 3013896610, 3014856521, 3013679558, 3032948391, 3007307487, 2434008, 3014848734, 3003072803, 9610816, 2025816, 3003971136, 3018008670, 1835242, 3008483389, 3010405299, 3008011951, 3038761440 +439 more
FEI number
3006852457, 2648045, 3003965134, 3008729547, 3008167616, 3003589956, 3012302888, 1000208624, 3006469671, 3006078362, 3013019728, 3038295706, 1314417, 3017896172, 3015768317, 3010390468, 3004111573, 3016674095, 3027285900, 3043226252, 3014541700, 3009156722, 3024512705, 1000116158, 3043513123, 3003622639, 3013896610, 3014856521, 3013679558, 3032948391, 3007307487, 2434008, 3014848734, 3003072803, 2025816, 3003971136, 3018008670, 3008483389, 3010405299, 3008011951 +439 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.