510(k) K142263
K142263 is an FDA 510(k) premarket notification submitted by Shanghai Mediworks Precision Instruments Co. , Ltd. for the device "Applanation Tonometer". The FDA issued a decision of Substantially Equivalent on April 15, 2016. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Shanghai Mediworks Precision Instruments Co. , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 2016
- Date Received
- August 14, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tonometer, Manual
- Device Class
- Class II
- Regulation Number
- 886.1930
- Review Panel
- OP
- Submission Type