510(k) K111715
K111715 is an FDA 510(k) premarket notification submitted by Unisense Fertilitech A/S for the device "EMBRYOSCOPE". The FDA issued a decision of Substantially Equivalent on August 11, 2011. The device falls under product code MQG (Accessory, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6120. Unisense Fertilitech A/S has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 2011
- Date Received
- June 20, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessory, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6120
- Review Panel
- OB
- Submission Type