510(k) K090324
K090324 is an FDA 510(k) premarket notification submitted by Sti Medical Systems for the device "ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY". The FDA issued a decision of Substantially Equivalent on December 20, 2010. The device falls under product code HEX (Colposcope (And Colpomicroscope)), a Class II device regulated under 21 CFR 884.1630. Sti Medical Systems has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2010
- Date Received
- February 9, 2009
- 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