510(k) DEN140017
DEN140017 is an FDA 510(k) premarket notification submitted by Sensimed AG for the device "SENSIMED TRIGGERFISH". The FDA issued a decision of De Novo Granted on March 4, 2016. The device falls under product code PLZ (Ocular Pattern Recorder), a Class II device regulated under 21 CFR 886.1925.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 4, 2016
- Date Received
- May 6, 2014
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ocular Pattern Recorder
- Device Class
- Class II
- Regulation Number
- 886.1925
- Review Panel
- OP
- Submission Type
A diurnal pattern recorder system is a non-implantable, prescription device incorporating a telemetric sensor intended to detect changes in ocular dimension for monitoring diurnal patterns of IOP fluctuation.