510(k) K100237
K100237 is an FDA 510(k) premarket notification submitted by Myron L Company for the device "DIALYSATE METER, MODEL D-6". The FDA issued a decision of Substantially Equivalent on April 23, 2010. The device falls under product code FLB (Meter, Conductivity, Induction, Remote Type), a Class II device regulated under 21 CFR 876.5820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 2010
- Date Received
- January 26, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Meter, Conductivity, Induction, Remote Type
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type