510(k) K031436
K031436 is an FDA 510(k) premarket notification submitted by Sometech Corporation for the device "MEDISCOPE". The FDA issued a decision of Substantially Equivalent on Dec 19, 2003. The device falls under product code HEX (Colposcope (And Colpomicroscope)), a Class II device regulated under 21 CFR 884.1630. Sometech Corporation has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 19, 2003
- Date Received
- May 6, 2003
- 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
- 510(k)