The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies, Inc. with the FDA for Carescape One And Carescape Dock F0, Model Numbers Mbz323 And Mfa101, Carescape Ecg, Model Number Mke101,carescape Temp, Model Number Mkt101, Carescape Pres, Model Number Mkp101, Carescape Spo2, Model Numbers Mks101 And Mks201.
| Device ID | K213234 |
| 510k Number | K213234 |
| Device Name: | CARESCAPE ONE And CARESCAPE DOCK F0, Model Numbers MBZ323 And MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 And MKS201 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226 |
| Contact | Joel Kent |
| Correspondent | Joel Kent GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226 |
| Product Code | MHX |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DPZ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DQK |
| 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 |
| Subsequent Product Code | MUD |
| Subsequent Product Code | QEM |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-30 |
| Decision Date | 2022-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278288639 | K213234 | 000 |