510(k) K043098
K043098 is an FDA 510(k) premarket notification submitted by Gerber Products Co. for the device "GERBER DOUBLE ELECTRIC BREAST PUMP". The FDA issued a decision of Substantially Equivalent on December 15, 2004. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Gerber Products Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 2004
- Date Received
- November 9, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Pump, Breast, Powered
- Device Class
- Class II
- Regulation Number
- 884.5160
- Review Panel
- OB
- Submission Type