510(k) K172989
K172989 is an FDA 510(k) premarket notification submitted by Joytech Healthcare Co. , Ltd. for the device "Electric Breast Pump". The FDA issued a decision of Substantially Equivalent on Dec 20, 2017. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Joytech Healthcare Co. , Ltd. has 22 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 20, 2017
- Date Received
- Sep 27, 2017
- 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
- 510(k)