510(k) K122311
K122311 is an FDA 510(k) premarket notification submitted by Shenzhen Goldcare Meditech Co., Ltd. for the device "GC-3000E DIGITAL COLPOSCOPE". The FDA issued a decision of Substantially Equivalent on September 18, 2013. The device falls under product code HEX (Colposcope (And Colpomicroscope)), a Class II device regulated under 21 CFR 884.1630.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2013
- Date Received
- August 1, 2012
- 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