Clearance Summary
PHON/STRESS SYSTEM (#21126A) received FDA 510(k) clearance under submission number K760464, sponsored by Hewlett-Packard Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1976-08-30.
- Submission: K760464
- Applicant / Sponsor: Hewlett-Packard Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.2390
- Decision date: 1976-08-30
Classification & Regulation
This clearance is catalogued under FDA product code DQC and 21 CFR 870.2390, within the Cardiovascular review panel as a Class I device.