Clearance Summary
IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 received FDA 510(k) clearance under submission number K022062, sponsored by Impact Instrumentation, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2003-05-06.
- Submission: K022062
- Applicant / Sponsor: Impact Instrumentation, Inc.
- Clearance pathway: Abbreviated
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5895
- Decision date: 2003-05-06
Classification & Regulation
This clearance is catalogued under FDA product code MOD and 21 CFR 868.5895, within the Anesthesiology review panel as a Class II device.