510(k) clearances

Arm-type Fully Automatic Digital Blood Pressure Monitor

Joytech Healthcare Co. , Ltd. · Cardiovascular

K231303Substantially EquivalentTraditionalDXN
Open FDA's page for this record
Third party flag
N
City
Hangzhou
Advisory committee description
Cardiovascular
Address 1
# 365. Wuzhou Rd., Yuhang Economic Development Zone
Statement or summary
Summary
Product code
DXN
Zip code
311100
Applicant
Joytech Healthcare Co. , Ltd.
Decision date
2024-01-26
Decision code
SESE
Country code
CN
Device name
Arm-type Fully Automatic Digital Blood Pressure Monitor
Advisory committee
CV
Contact
Ren Yunhua
K number
K231303
Date received
2023-05-05
Review advisory committee
CV
Postal code
311100
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.