K222143
- 510(k) number
- K222143
- Device name
- APIS (R), VERIS (TM)
- Applicant
- Sweetbio, Inc. TN · US
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2023-10-13
- Date received
- 2022-07-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
510(k) Summary (official FDA PDF): K222143.pdf
Official FDA record: K222143
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.