Clearance Summary
DIGITAL PULSE METER (73 BWS) #HRM-100E received FDA 510(k) clearance under submission number K822692, sponsored by Sanyo Electric, 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 1982-10-15.
- Submission: K822692
- Applicant / Sponsor: Sanyo Electric, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 1982-10-15
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.