aetherSlide
FDA 510(k) clearance K233126 · decided 2024-05-30
Clearance details
- K-number
- K233126
- Device name
- aetherSlide
- Applicant
- Aetherai Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-27
- Decision date
- 2024-05-30
- Days to decision
- 246 days
- Clearance type
- Traditional
- Product code
- QKQ
- Device class
- 2
- Regulation number
- 864.3700
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Taipei City, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.