510(k) clearances

Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)

Unimed Medical Supplies, Inc. · Cardiovascular

K243086Substantially EquivalentTraditionalDQA
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
Cardiovascular
Address 1
Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, Baoan D
Statement or summary
Summary
Product code
DQA
Zip code
518108
Applicant
Unimed Medical Supplies, Inc.
Decision date
2025-02-20
Decision code
SESE
Country code
CN
Device name
Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)
Advisory committee
CV
Contact
Huanyu Zeng
K number
K243086
Date received
2024-09-30
Review advisory committee
AN
Postal code
518108
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Oximeter
Medical specialty description
Cardiovascular
Regulation number
870.2700
Device class
2
Registration number
3044675072, 3010526986, 3017953522, 3003965134, 3008729547, 3006713849, 3003589956, 2029015, 3012302888, 1314417, 3010390468, 3016674095, 3014541700, 3009156722, 3024512705, 3007699081, 3016170326, 3003622639, 3043513123, 9614500, 3013896610, 3014856521, 3013679558, 3032948391, 3007307487, 2434008, 3014848734, 3004091281, 9610816, 3032391, 2025816, 9617566, 3003971136, 2022648, 3008483389, 3038761440, 8020893, 8021084, 3007603826, 3012933969 +357 more
FEI number
3044675072, 3010526986, 3017953522, 3003965134, 3008729547, 3006713849, 3003589956, 3012302888, 1000292048, 1314417, 3010390468, 3016674095, 3014541700, 3009156722, 3024512705, 3007699081, 3016170326, 3003622639, 3043513123, 3013896610, 3014856521, 3013679558, 3003794634, 3032948391, 3007307487, 2434008, 3014848734, 2025816, 3003971136, 2022648, 3006254866, 3002663379, 3008483389, 3038761440, 3007603826, 3012933969, 3014233600, 3013596024, 3010082909, 3003630387 +357 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.