510(k) K191314
K191314 is an FDA 510(k) premarket notification submitted by Chongqing Sunkingdom Medical Instrument Co., Ltd. for the device "Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q". The FDA issued a decision of Substantially Equivalent on December 19, 2019. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Chongqing Sunkingdom Medical Instrument Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2019
- Date Received
- May 15, 2019
- 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