Clearance Summary
LOG-A-RYTHM MODEL 100 AND MODEL 1001 received FDA 510(k) clearance under submission number K952790, sponsored by Nian-Crae, 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 1996-10-17.
- Submission: K952790
- Applicant / Sponsor: Nian-Crae, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 1996-10-17
Classification & Regulation
This clearance is catalogued under FDA product code DRT and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.