Clearance Summary
TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205 received FDA 510(k) clearance under submission number K081498, sponsored by Biocomfort Diagnostics GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-12-17.
- Submission: K081498
- Applicant / Sponsor: Biocomfort Diagnostics GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2008-12-17
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.