The following data is part of a premarket notification filed by Medical Informatics Corp with the FDA for Sickbay Clinical Platform.
| Device ID | K143304 |
| 510k Number | K143304 |
| Device Name: | Sickbay Clinical Platform |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Medical Informatics Corp 6500 Main Street Suite 1020G Houston, TX 77030 |
| Contact | Ralph Krog |
| Correspondent | David Makanani OMEDtech, LLC 1725 Signal Ridge Drive, Suite 150 Edmond, OK 73013 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-18 |
| Decision Date | 2015-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B693SICKBAY0301210 | K143304 | 000 |
| B693SICKBAY0301200 | K143304 | 000 |
| B693SICKBAY0301240 | K143304 | 000 |
| B693SICKBAY034000 | K143304 | 000 |
| B693SICKBAY034100 | K143304 | 000 |
| B693SICKBAY034200 | K143304 | 000 |
| B693SICKBAY034300 | K143304 | 000 |