510(k) K173264
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 2018
- Date Received
- October 11, 2017
- 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