The following data is part of a premarket notification filed by Infinium Medical with the FDA for Omni Patent Monitors.
| Device ID | K132229 |
| 510k Number | K132229 |
| Device Name: | OMNI PATENT MONITORS |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | INFINIUM MEDICAL 445 APOLLO BEACH BLVD Apollo Beach, FL 33572 |
| Contact | John O'brien |
| Correspondent | John O'brien INFINIUM MEDICAL 445 APOLLO BEACH BLVD Apollo Beach, FL 33572 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-18 |
| Decision Date | 2014-02-21 |
| Summary: | summary |