510(k) K172182
K172182 is an FDA 510(k) premarket notification submitted by St. Jude Medical (Now Part Of The Abbott Medical) for the device "QUANTIEN Measurement System". The FDA issued a decision of Substantially Equivalent on Aug 18, 2017. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 18, 2017
- Date Received
- Jul 19, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type
- 510(k)