510(k) K895609
K895609 is an FDA 510(k) premarket notification submitted by Pulse Medical Instruments for the device "PUPIL PATHWAY ANALYZER (PPA)". The FDA issued a decision of Substantially Equivalent on November 2, 1989. The device falls under product code HLG (Pupillometer, Ac-Powered), a Class I device regulated under 21 CFR 886.1700.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 1989
- Date Received
- September 18, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pupillometer, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 886.1700
- Review Panel
- OP
- Submission Type