510(k) K172481
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2017
- Date Received
- August 16, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type