Clearance Summary
STETH-SHIELD ACCESSORY TO A STETHOSCOPE received FDA 510(k) clearance under submission number K882324, sponsored by Steth-Shield, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1988-07-18.
- Submission: K882324
- Applicant / Sponsor: Steth-Shield, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.1875
- Decision date: 1988-07-18
Classification & Regulation
This clearance is catalogued under FDA product code LDE and 21 CFR 870.1875, within the Cardiovascular review panel as a Class I device.