K233906
- 510(k) number
- K233906
- Device name
- S-Patch (S-Patch ExL)
- Applicant
- Wellysis Corp. KR
- Product code
- DSH — Recorder, Magnetic Tape, Medical
- Decision date
- 2024-02-16
- Date received
- 2023-12-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K233906.pdf
Official FDA record: K233906
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.