The following data is part of a premarket notification filed by Infinium Medical with the FDA for Cleo Patient Monitor.
| Device ID | K142244 |
| 510k Number | K142244 |
| Device Name: | CLEO PATIENT MONITOR |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | INFINIUM MEDICAL 12151 62ND STREET NORTH # 5 Largo, FL 33773 |
| Contact | Suleyman Bilgutay |
| Correspondent | John O'brien AJW TECHNOLOGY CONSULTANTS, INC. 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 | 2014-08-13 |
| Decision Date | 2015-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815871021951 | K142244 | 000 |