K260157
- 510(k) number
- K260157
- Device name
- LifeLens Physiological Monitor
- Applicant
- LifeLens Technologies, Inc. PA · US
- Product code
- DSH — Recorder, Magnetic Tape, Medical
- Decision date
- 2026-07-09
- Date received
- 2026-01-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K260157.pdf
Official FDA record: K260157
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.