The following data is part of a premarket notification filed by Rand S.r.l. with the FDA for Performer Cbp System.
| Device ID | K070213 |
| 510k Number | K070213 |
| Device Name: | PERFORMER CBP SYSTEM |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | RAND S.R.L. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Preeti Jain |
| Correspondent | Preeti Jain RAND S.R.L. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-22 |
| Decision Date | 2007-03-21 |
| Summary: | summary |