510(k) K160341
K160341 is an FDA 510(k) premarket notification submitted by Xuzhou Kernel Medical Equipment Co., Ltd. for the device "Colposcope System". The FDA issued a decision of Substantially Equivalent on September 14, 2016. The device falls under product code HEX (Colposcope (And Colpomicroscope)), a Class II device regulated under 21 CFR 884.1630. Xuzhou Kernel Medical Equipment Co., Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2016
- Date Received
- February 8, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colposcope (And Colpomicroscope)
- Device Class
- Class II
- Regulation Number
- 884.1630
- Review Panel
- OB
- Submission Type