FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
CARESCAPE B450, E-musb
K Number: K213363
·
Decision Apr 13, 2022
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
411
Applicant Total
8
Review Days
183
Basic Information
- Device Name
- CARESCAPE B450, E-musb
- K Number
- K213363
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE Healthcare Finland Oy
- Date Received
- October 12, 2021
- Decision Date
- April 13, 2022
- Product Code
- MHX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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Other Clearances by GE Healthcare Finland Oy
| K Number | Device Name | ||
|---|---|---|---|
| K223531 | CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) | Apr 6, 2023 | Substantially Equivalent |
| K213181 | CARESCAPE B650, E-musb | Apr 13, 2022 | Substantially Equivalent |
| K211171 | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories | Oct 21, 2021 | Substantially Equivalent |
| K191249 | CARESCAPE B450 | Jan 24, 2020 | Substantially Equivalent |
| K191322 | E-EEGX, N-EEGX | Jan 22, 2020 | Substantially Equivalent |
| K191149 | CARESCAPE B650 | Jan 21, 2020 | Substantially Equivalent |
| K183394 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO | May 1, 2019 | Substantially Equivalent |