K242583
- 510(k) number
- K242583
- Device name
- AT-Patch (ATP-C130/ATP-C70)
- Applicant
- Atsens Co., Ltd. KR
- Product code
- DSH — Recorder, Magnetic Tape, Medical
- Decision date
- 2025-05-02
- Date received
- 2024-08-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K242583.pdf
Official FDA record: K242583
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.