FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Change Healthcare Cardiology Hemodynamics
K Number: K230881
·
Decision Sep 11, 2023
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
305
Applicant Total
3
Review Days
165
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Change Healthcare Cardiology Hemodynamics
- K Number
- K230881
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Change Healthcare Israel , Ltd.
- Date Received
- March 30, 2023
- Decision Date
- September 11, 2023
- Product Code
- MWI
- 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 |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MWI), ordered by most recent decision date.
Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)
FDA 510(k)
FDA Class 2
·Cardiovascular
c-med0 alpha
FDA 510(k)
FDA Class 2
·Cardiovascular
WAVE Clinical Platform (2.0.000)
FDA 510(k)
FDA Class 2
·Cardiovascular
QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
FDA 510(k)
FDA Class 2
·Cardiovascular
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
FDA 510(k)
FDA Class 2
·Cardiovascular
WARD-CSS (v1.2.x)
FDA 510(k)
FDA Class 2
·Cardiovascular