Identifiers
- 510(k) Number
- K131027 FDA 510(k)
- FDA Product Code
- HGX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5160 FDA 510(k)
- Regulation Number
- 884.5160 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Memory Pump Model Y4947 is a powered breast pump designed to express and collect milk from the breast. It functions as a double electric breast pump.
This device is intended for use by a single user. It has received FDA 510(k) clearance.
Frequently asked questions
What is the primary function of the Memory Pump Model Y4947?
This device is a powered breast pump designed to express and collect milk from the breast. It operates as a double electric breast pump to assist with milk expression.
Is the Memory Pump Model Y4947 intended for multiple users?
No, this device is intended for use by a single user only. Sharing breast pumps can pose hygiene risks and may affect the performance of the device.
Has this device received regulatory clearance?
Yes, the Memory Pump Model Y4947 has received FDA 510(k) clearance under the regulation number 884.5160.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MEMORY PUMP MODEL Y4947 (K131027) — FDA 510 (k) | Innolitics, MEMORY PUMP MODEL Y4947 by TOMY INTERNATIONAL | FDA 510 (k) Summary, The First Years Breastflow Memory Pump Y4947 Instruction Manual, The First Years Breastflow Memory Pump Y4947 Instruction Manual, The First Years Breastflow Memory Pump Y4947 Manuals
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131027 | Class II | Active |
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Manufacturer
- Manufacturer
- TOMY International
Sources (1)
- FDA 510(k) K131027 24 fields · synced Sep 22, 2026