510(k) K100439
K100439 is an FDA 510(k) premarket notification submitted by Shanghai Mediworks Precision Instruments Co. , Ltd. for the device "MEDIWORKS SLIT LAMP". The FDA issued a decision of Substantially Equivalent on July 16, 2010. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Shanghai Mediworks Precision Instruments Co. , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 2010
- Date Received
- February 17, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biomicroscope, Slit-Lamp, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type