AITRICS-VC
FDA 510(k) clearance K240756 · decided 2024-07-23
Clearance details
- K-number
- K240756
- Device name
- AITRICS-VC
- Applicant
- Aitrics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-03-20
- Decision date
- 2024-07-23
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- PLB
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.