Clearance Summary
HL 200 ELECTRONIC STETHOSCOPE received FDA 510(k) clearance under submission number K050169, sponsored by Health & Life Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2005-04-05.
- Submission: K050169
- Applicant / Sponsor: Health & Life Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1875
- Decision date: 2005-04-05
Classification & Regulation
This clearance is catalogued under FDA product code DQD and 21 CFR 870.1875, within the Cardiovascular review panel as a Class II device.