Clearance Summary
TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST received FDA 510(k) clearance under submission number K912045, sponsored by Lifestream Int'L, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1991-10-31.
- Submission: K912045
- Applicant / Sponsor: Lifestream Int'L, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4310
- Decision date: 1991-10-31
Classification & Regulation
This clearance is catalogued under FDA product code DXS and 21 CFR 870.4310, within the Cardiovascular review panel as a Class II device.