Clearance Summary
BILATERAL IMPEDANCE PLETHYSMOGRAPH, BIP(TM) received FDA 510(k) clearance under submission number K862714, sponsored by Electro-Diagnostic Instruments. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1986-11-17.
- Submission: K862714
- Applicant / Sponsor: Electro-Diagnostic Instruments
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 1986-11-17
Classification & Regulation
This clearance is catalogued under FDA product code DSB and 21 CFR 870.2770, within the Cardiovascular review panel as a Class II device.