The following data is part of a premarket notification filed by Witt Biomedical Corp with the FDA for Xper Information Management And Flex Cardio Physiomonitoring Systems.
| Device ID | K101571 |
| 510k Number | K101571 |
| Device Name: | XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | WITT BIOMEDICAL CORP 305 NORTH DR. Melbourne, FL 32934 |
| Contact | James Luker |
| Correspondent | James Luker WITT BIOMEDICAL CORP 305 NORTH DR. Melbourne, FL 32934 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-04 |
| Decision Date | 2010-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838091474 | K101571 | 000 |
| 00884838070721 | K101571 | 000 |
| 00884838070691 | K101571 | 000 |
| 00884838093645 | K101571 | 000 |
| 00884838095069 | K101571 | 000 |
| 00884838095052 | K101571 | 000 |
| 00884838093782 | K101571 | 000 |
| 00884838093775 | K101571 | 000 |
| 00884838093652 | K101571 | 000 |
| 00884838091771 | K101571 | 000 |
| 00884838098985 | K101571 | 000 |
| 00884838100084 | K101571 | 000 |
| 00884838103245 | K101571 | 000 |
| 00884838081291 | K101571 | 000 |
| 00884838082113 | K101571 | 000 |
| 00884838087330 | K101571 | 000 |
| 00884838086012 | K101571 | 000 |
| 00884838086005 | K101571 | 000 |
| 00884838085213 | K101571 | 000 |
| 00884838084933 | K101571 | 000 |
| 00884838084926 | K101571 | 000 |
| 00884838084919 | K101571 | 000 |
| 00884838084902 | K101571 | 000 |
| 00884838083820 | K101571 | 000 |
| 00884838083530 | K101571 | 000 |
| 00884838083523 | K101571 | 000 |
| 00884838083516 | K101571 | 000 |
| 00884838103610 | K101571 | 000 |