Clearance Summary
MAXISTIM received FDA 510(k) clearance under submission number K955031, sponsored by Life-Tech Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1996-12-10.
- Submission: K955031
- Applicant / Sponsor: Life-Tech Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2775
- Decision date: 1996-12-10
Classification & Regulation
This clearance is catalogued under FDA product code KOI and 21 CFR 868.2775, within the Anesthesiology review panel as a Class II device.