The following data is part of a premarket notification filed by Levitronix Llc. with the FDA for Levitronix 2nd Generation Centrimag Primary Console, Levitronix Monitor.
| Device ID | K102129 |
| 510k Number | K102129 |
| Device Name: | LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR |
| Classification | Control, Pump Speed, Cardiopulmonary Bypass |
| Applicant | LEVITRONIX LLC. 45 FIRST AVE. Waltham, MA 02451 |
| Contact | Farzad Parsaie |
| Correspondent | Farzad Parsaie LEVITRONIX LLC. 45 FIRST AVE. Waltham, MA 02451 |
| Product Code | DWA |
| CFR Regulation Number | 870.4380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-29 |
| Decision Date | 2010-08-27 |
| Summary: | summary |