The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Carescape One And Carescape Dock Fo, Carescape Ecg, Carescape Temp, Carescape Pres.
| Device ID | K200494 |
| 510k Number | K200494 |
| Device Name: | CARESCAPE ONE And CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE Healthcare 8200 West Tower Avenue Milwaukee, WI 53223 |
| Contact | Joel Kent |
| Correspondent | Joel Kent GE Healthcare 8200 West Tower Avenue Milwaukee, WI 53223 |
| Product Code | MHX |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | CAR |
| Subsequent Product Code | DPZ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DSJ |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | MLD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-28 |
| Decision Date | 2020-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682123976 | K200494 | 000 |
| 00840682123969 | K200494 | 000 |
| 00840682123952 | K200494 | 000 |
| 00840682123921 | K200494 | 000 |
| 00840682124799 | K200494 | 000 |
| 00840682124607 | K200494 | 000 |
| 00840682125901 | K200494 | 000 |