510(k) K172259
K172259 is an FDA 510(k) premarket notification submitted by Pulsion Medical Systems SE for the device "PulsioFlex Monitoring System". The FDA issued a decision of Substantially Equivalent on January 18, 2018. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Pulsion Medical Systems SE has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2018
- Date Received
- July 27, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Pre-Programmed, Single-Function
- Device Class
- Class II
- Regulation Number
- 870.1435
- Review Panel
- CV
- Submission Type