510(k) K895240
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 1989
- Date Received
- August 21, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluorometer, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2560
- Review Panel
- CH
- Submission Type