Clearance Summary
BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM received FDA 510(k) clearance under submission number K983717, sponsored by Aerotel Medical Systems (1998) , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-09-16.
- Submission: K983717
- Applicant / Sponsor: Aerotel Medical Systems (1998) , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1999-09-16
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.