510(k) K233428
K233428 is an FDA 510(k) premarket notification submitted by Guangzhou Easycess Medical Co.,Ltd for the device "Easycess Aspiration Pump". The FDA issued a decision of Substantially Equivalent on November 3, 2023. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Guangzhou Easycess Medical Co.,Ltd has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 2023
- Date Received
- October 11, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type