The following data is part of a premarket notification filed by Medos Medizintechnik Ag with the FDA for Medos Hilite Infant Oxygenator.
| Device ID | K140181 |
| 510k Number | K140181 |
| Device Name: | MEDOS HILITE INFANT OXYGENATOR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | MEDOS MEDIZINTECHNIK AG 3526 WEST LIBERTY RD. Ann Arbor, MI 48103 |
| Contact | Leann Christman |
| Correspondent | Leann Christman MEDOS MEDIZINTECHNIK AG 3526 WEST LIBERTY RD. Ann Arbor, MI 48103 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-24 |
| Decision Date | 2014-02-19 |
| Summary: | summary |