510(k) K190810
K190810 is an FDA 510(k) premarket notification submitted by Unimom.Co for the device "OPERA, OPERA eco". The FDA issued a decision of Substantially Equivalent on August 30, 2019. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Unimom.Co has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 2019
- Date Received
- March 29, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Breast, Powered
- Device Class
- Class II
- Regulation Number
- 884.5160
- Review Panel
- OB
- Submission Type