Boppli Infant Blood Pressure Monitor
FDA 510(k) clearance K223873 · decided 2023-09-29
Clearance details
- K-number
- K223873
- Device name
- Boppli Infant Blood Pressure Monitor
- Applicant
- Pyrames, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-12-23
- Decision date
- 2023-09-29
- Days to decision
- 280 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Cupertino, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 recall (Z-1508-2025) | PYRAMES INC | 2025-04-02 |