The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Carescape One.
| Device ID | K190008 |
| 510k Number | K190008 |
| Device Name: | Carescape One |
| 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 |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-02 |
| Decision Date | 2019-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843997013871 | K190008 | 000 |
| 00843997010832 | K190008 | 000 |