Clearance Summary
CALM PATTERNS, VERSION 01.00.00 received FDA 510(k) clearance under submission number K040788, sponsored by Lms Medical Systems , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2005-02-08.
- Submission: K040788
- Applicant / Sponsor: Lms Medical Systems , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 2005-02-08
Classification & Regulation
This clearance is catalogued under FDA product code HGM and 21 CFR 884.2740, within the Obstetrics/Gynecology review panel as a Class II device.