Clearance Summary
MODEL #05 ANEROID SPHYGMOMANOMETER KIT received FDA 510(k) clearance under submission number K913814, sponsored by National Health-Care Equipment, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1992-01-16.
- Submission: K913814
- Applicant / Sponsor: National Health-Care Equipment, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3070
- Decision date: 1992-01-16
Classification & Regulation
This clearance is catalogued under FDA product code ELY and 21 CFR 872.3070, within the Dental review panel as a Class II device.