510(k) K131589
K131589 is an FDA 510(k) premarket notification submitted by Keeler, Ltd. for the device "KEELER SLIT LAMP H-SERIES". The FDA issued a decision of Substantially Equivalent on June 27, 2013. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Keeler, Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2013
- Date Received
- May 31, 2013
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Biomicroscope, Slit-Lamp, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type