FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
K Number: K122121
·
Decision Aug 2, 2012
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
176
Applicant Total
4
Review Days
16
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
- PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
- K Number
- K122121
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1435
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pulsion Medical Systems SE
- Date Received
- July 17, 2012
- Decision Date
- August 2, 2012
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXG), ordered by most recent decision date.
Argos Infinity (Rev. 1.0)
FDA 510(k)
FDA Class 2
·Cardiovascular
VitalStream ART Connect; VitalStream-Hemo
FDA 510(k)
FDA Class 2
·Cardiovascular
Cogent Hemodynamic Monitoring System; Cogent HMS
FDA 510(k)
FDA Class 2
·Cardiovascular
Hypotension Decision Assist Model HDA-OR2
FDA 510(k)
FDA Class 2
·Cardiovascular
PulsioFlex Monitoring System with ProAQT Sensor
FDA 510(k)
FDA Class 2
·Cardiovascular
EV1000 Clinical Platform
FDA 510(k)
FDA Class 2
·Cardiovascular