FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)
K Number: K253152
·
Decision May 6, 2026
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
1
Review Days
222
Basic Information
- Device Name
- BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)
- K Number
- K253152
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biozen, LLC
- Date Received
- September 26, 2025
- Decision Date
- May 6, 2026
- Product Code
- DXN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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