The following data is part of a premarket notification filed by Infinium Medical with the FDA for Omni Patient Monitor.
| Device ID | K112329 |
| 510k Number | K112329 |
| Device Name: | OMNI PATIENT MONITOR |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | INFINIUM MEDICAL 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Contact | John O'brien |
| Correspondent | John O'brien INFINIUM MEDICAL 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Product Code | MWI |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-12 |
| Decision Date | 2011-09-08 |
| Summary: | summary |