The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Borla Transducer Protector & Haemotronic Transducer Protector.
| Device ID | K000702 |
| 510k Number | K000702 |
| Device Name: | BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR |
| Classification | Protector, Transducer, Dialysis |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA TWO LEDGEMONT CENTER 95 HAYDEN AVENUE Lexington, MA 02420 |
| Contact | Arthur Eilinsfeld |
| Correspondent | Arthur Eilinsfeld FRESENIUS MEDICAL CARE NORTH AMERICA TWO LEDGEMONT CENTER 95 HAYDEN AVENUE Lexington, MA 02420 |
| Product Code | FIB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-01 |
| Decision Date | 2000-06-07 |