The following data is part of a premarket notification filed by Yankee Intl. Medical Research & Mfg., Ltd. with the FDA for Ufr Digital Retrofit.
| Device ID | K875312 |
| 510k Number | K875312 |
| Device Name: | UFR DIGITAL RETROFIT |
| Classification | Detector, Dialysate Level |
| Applicant | YANKEE INTL. MEDICAL RESEARCH & MFG., LTD. P.O. BOX 151 Manchese, NH 03105 -0151 |
| Contact | D. W Brous |
| Correspondent | D. W Brous YANKEE INTL. MEDICAL RESEARCH & MFG., LTD. P.O. BOX 151 Manchese, NH 03105 -0151 |
| Product Code | FJB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-29 |
| Decision Date | 1988-02-19 |