PRESSUREALERT® Pressure Monitoring System
FDA 510(k) clearance K233096 · decided 2024-06-21
Clearance details
- K-number
- K233096
- Device name
- PRESSUREALERT® Pressure Monitoring System
- Applicant
- Position Health, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-09-26
- Decision date
- 2024-06-21
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- SBO
- Device class
- 1
- Regulation number
- 880.2400
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lake Forest, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.