Clearance Summary
DIALYSATE METER, MODEL D-6 received FDA 510(k) clearance under submission number K100237, sponsored by Myron L Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2010-04-23.
- Submission: K100237
- Applicant / Sponsor: Myron L Company
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2010-04-23
Classification & Regulation
This clearance is catalogued under FDA product code FLB and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.