K261494
- 510(k) number
- K261494
- Device name
- Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)
- Applicant
- Shanghai Hulu Devices Co., Ltd. CN
- Product code
- DQD — Stethoscope, Electronic
- Decision date
- 2026-07-31
- Date received
- 2026-05-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K261494.pdf
Official FDA record: K261494
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.