The following data is part of a premarket notification filed by Infinium Medical with the FDA for Omni Iii Patient Monitor.
| Device ID | K101052 |
| 510k Number | K101052 |
| Device Name: | OMNI III PATIENT MONITOR |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | INFINIUM MEDICAL 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Contact | John Obrien |
| Correspondent | John Obrien INFINIUM MEDICAL 962 ALLEGRO LN. 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 | 2010-04-15 |
| Decision Date | 2010-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815871021937 | K101052 | 000 |