Clearance Summary
NARCO TLECARE MINIATURE PRESSURE DOME received FDA 510(k) clearance under submission number K810431, sponsored by Narco Bio-Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1981-03-11.
- Submission: K810431
- Applicant / Sponsor: Narco Bio-Systems
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2850
- Decision date: 1981-03-11
Classification & Regulation
This clearance is catalogued under FDA product code DRS and 21 CFR 870.2850, within the Cardiovascular review panel as a Class II device.