The following data is part of a premarket notification filed by Fresenius Medical Care North America, Design Cente with the FDA for Bvm Hemodialysis Blood Tubing Set With Attached Priming Set And Transducer Protectors.
| Device ID | K120823 |
| 510k Number | K120823 |
| Device Name: | BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE 920 Winter Street Waltham, MA 02451 -1457 |
| Contact | Denise Oppermann |
| Correspondent | Denise Oppermann FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE 920 Winter Street Waltham, MA 02451 -1457 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-19 |
| Decision Date | 2012-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840861100474 | K120823 | 000 |