510(k) K181398
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2018
- Date Received
- May 29, 2018
- Clearance Type
- Traditional
- 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