Clearance Summary
DIGITAL BPM received FDA 510(k) clearance under submission number K790036, sponsored by Narco Air-Shields. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1979-03-02.
- Submission: K790036
- Applicant / Sponsor: Narco Air-Shields
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2870
- Decision date: 1979-03-02
Classification & Regulation
This clearance is catalogued under FDA product code DXO and 21 CFR 870.2870, within the Cardiovascular review panel as a Class II device.