K233855
- 510(k) number
- K233855
- Device name
- AllPEP
- Applicant
- Enchant Tek Co. , Ltd. TW
- Product code
- BWF — Spirometer, Therapeutic (Incentive)
- Decision date
- 2024-02-02
- Date received
- 2023-12-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233855.pdf
Official FDA record: K233855
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.