510(k) K093218
K093218 is an FDA 510(k) premarket notification submitted by Fem Suite, LLC for the device "FEMEYE TWO". The FDA issued a decision of Substantially Equivalent on May 18, 2010. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Fem Suite, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 2010
- Date Received
- October 13, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hysteroscope (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1690
- Review Panel
- OB
- Submission Type