510(k) K260194
K260194 is an FDA 510(k) premarket notification submitted by Sheng Sheng Yi (Beijing) Technology Company Limited for the device "Vacuum Pump (Model: AD-VPUM-500)". The FDA issued a decision of Substantially Equivalent on April 28, 2026. The device falls under product code MQG (Accessory, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6120.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2026
- Date Received
- January 22, 2026
- 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