510(k) K100595
K100595 is an FDA 510(k) premarket notification submitted by Ecleris USA for the device "ECLERIS MICROSTAR COLPOSCOPE". The FDA issued a decision of Substantially Equivalent on July 9, 2010. The device falls under product code HEX (Colposcope (And Colpomicroscope)), a Class II device regulated under 21 CFR 884.1630. Ecleris USA has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 2010
- Date Received
- March 2, 2010
- 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