LetsGetChecked Impress
FDA 510(k) clearance K242680 · decided 2025-01-13
Clearance details
- K-number
- K242680
- Device name
- LetsGetChecked Impress
- Applicant
- Privapath Diagnostics Ltd (Dba Letsgetchecked)
- Decision
- Unknown
- Date received
- 2024-09-06
- Decision date
- 2025-01-13
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- FMK
- Device class
- 2
- Regulation number
- 878.4850
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Dublin, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.