OMNI EXPRESS
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
INFINIUM MEDICAL
The following data is part of a premarket notification filed by Infinium Medical with the FDA for Omni Express.
Pre-market Notification Details
| Device ID | K103268 |
| 510k Number | K103268 |
| Device Name: | OMNI EXPRESS |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-04 |
| Decision Date | 2010-11-23 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815871021920 | K103268 | 000 |
Trademark Results [OMNI EXPRESS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OMNI EXPRESS 74532850 1905894 Live/Registered |
OMNI HOTELS MANAGEMENT CORPORATION 1994-06-03 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.