K241152
- 510(k) number
- K241152
- Device name
- InSee
- Applicant
- Tidal Medical Technologies, LLC CA · US
- Product code
- BWF — Spirometer, Therapeutic (Incentive)
- Decision date
- 2025-08-21
- Date received
- 2024-04-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K241152.pdf
Official FDA record: K241152
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.