510(k) clearances

Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)

Shenzhen Bsx Technology Electronics Co., Ltd. · Cardiovascular

K241578Substantially EquivalentTraditionalDXN
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
Cardiovascular
Address 1
Rm101&2/F~4/F, Bldg. #13, Ailian Industrial Park,
Address 2
Wulian Community, Longgang Distric
Statement or summary
Summary
Product code
DXN
Zip code
518116
Applicant
Shenzhen Bsx Technology Electronics Co., Ltd.
Decision date
2025-02-19
Decision code
SESE
Country code
CN
Device name
Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)
Advisory committee
CV
Contact
XiYu Lu
K number
K241578
Date received
2024-06-03
Review advisory committee
CV
Postal code
518116
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, Measurement, Blood-Pressure, Non-Invasive
Medical specialty description
Cardiovascular
Regulation number
870.1130
Device class
2
Registration number
2648045, 3015236197, 3008729547, 3008167616, 3009456923, 3003589956, 3012302888, 3017896172, 3003193933, 3013445220, 3010390468, 3016674095, 3043226252, 3033589330, 3014541700, 3009156722, 3024512705, 3016170326, 3003622639, 3043513123, 3004727093, 3013896610, 3032948391, 3013679558, 3009690509, 9710654, 2434008, 3031789039, 9610816, 3038620598, 2025816, 3005737664, 3003971136, 3018008670, 3013561145, 3008483389, 3010405299, 3008011951, 3038761440, 3007603826 +387 more
FEI number
2648045, 3015236197, 3008729547, 3008167616, 3009456923, 3003589956, 3012302888, 1000292048, 3017896172, 3003193933, 3013445220, 3010390468, 3016674095, 3043226252, 3033589330, 3014541700, 3009156722, 3024512705, 3016170326, 3003622639, 3043513123, 3004727093, 3013896610, 3032948391, 3013679558, 3002806476, 3009690509, 2434008, 3031789039, 3038620598, 2025816, 3005737664, 3003971136, 3018008670, 3013561145, 3008483389, 3010405299, 3008011951, 3038761440, 3007603826 +387 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.