Clearance Summary
ANEROID BLOOD PRESSURE GAUGE received FDA 510(k) clearance under submission number K904376, sponsored by Biomedical Dynamics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1990-12-20.
- Submission: K904376
- Applicant / Sponsor: Biomedical Dynamics, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1500
- Decision date: 1990-12-20
Classification & Regulation
This clearance is catalogued under FDA product code FCY and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class I device.