FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
PulsioFlex Monitoring System with ProAQT Sensor
K Number: K192169
·
Decision Apr 30, 2020
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
176
Applicant Total
4
Review Days
265
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Basic Information
- Device Name
- PulsioFlex Monitoring System with ProAQT Sensor
- K Number
- K192169
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1435
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pulsion Medical Systems SE
- Date Received
- August 9, 2019
- Decision Date
- April 30, 2020
- Product Code
- DXG
- 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 |
|---|---|---|---|
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | FDA class 2 | Cardiovascular |
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