Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)
FDA 510(k) clearance K242725 · decided 2025-05-30
Clearance details
- K-number
- K242725
- Device name
- Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)
- Applicant
- Ningbo Youhe Electrical Appliance Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-10
- Decision date
- 2025-05-30
- Days to decision
- 262 days
- Clearance type
- Traditional
- Product code
- HGX
- Device class
- 2
- Regulation number
- 884.5160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Cixi, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.