510(k) K013110
K013110 is an FDA 510(k) premarket notification submitted by Optical Diagnostics, Inc. for the device "ANISEIKONIA INSPECTOR". The FDA issued a decision of Substantially Equivalent on December 19, 2001. The device falls under product code HJT (Haploscope), a Class I device regulated under 21 CFR 886.1340.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2001
- Date Received
- July 11, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Haploscope
- Device Class
- Class I
- Regulation Number
- 886.1340
- Review Panel
- OP
- Submission Type