510(k) K000637
Clearance Details
- Decision
- SESU ()
- Decision Date
- May 19, 2000
- Date Received
- February 25, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aberrometer, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.1760
- Review Panel
- OP
- Submission Type