Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)
FDA 510(k) clearance K261136 · decided 2026-07-23
Clearance details
- K-number
- K261136
- Device name
- Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)
- Applicant
- Guangzhou Daxin Health Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2026-04-07
- Decision date
- 2026-07-23
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Guangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.