510(k) K875312
K875312 is an FDA 510(k) premarket notification submitted by Yankee Intl. Medical Research & Mfg., Ltd. for the device "UFR DIGITAL RETROFIT". The FDA issued a decision of Substantially Equivalent on February 19, 1988. The device falls under product code FJB (Detector, Dialysate Level), a Class II device regulated under 21 CFR 876.5820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1988
- Date Received
- December 29, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detector, Dialysate Level
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type