510(k) clearances

Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)

Jiangxi AOV Maternity & Baby Products Co., Ltd. · Obstetrics/Gynecology

K232477Substantially EquivalentTraditionalHGX
Open FDA's page for this record
Third party flag
N
City
Guixi
Advisory committee description
Obstetrics/Gynecology
Address 1
8. Nanhuan Rd., Industrial Park
Statement or summary
Summary
Product code
HGX
Zip code
335400
Applicant
Jiangxi AOV Maternity & Baby Products Co., Ltd.
Decision date
2024-05-09
Decision code
SESE
Country code
CN
Device name
Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)
Advisory committee
OB
Contact
Huang Xueping
K number
K232477
Date received
2023-08-16
Review advisory committee
OB
Postal code
335400
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Pump, Breast, Powered
Medical specialty description
Obstetrics/Gynecology
Regulation number
884.5160
Device class
2
Registration number
3006852457, 3009974348, 3010880718, 3002807523, 3020994856, 3027115730, 3014166044, 3030479957, 3003927385, 3009243271, 3003899230, 3012188053, 3020034975, 3009700166, 3021376102, 3038613158, 3012062596, 3031841858, 3015442469, 3010626066, 3016975995, 3013053058, 3013561139, 3012759464, 3010834934, 3015200642, 3011800804, 3042823784, 3012684779, 3030978471, 9710641, 1417592, 3008729914, 3016871906, 1419937, 3013684412, 3021544150, 3010334650, 2435947, 3002297831 +74 more
FEI number
3006852457, 3009974348, 3010880718, 3002807523, 3020994856, 3027115730, 3014166044, 3030479957, 3003927385, 3009243271, 3003899230, 3012188053, 3007429416, 3020034975, 3009700166, 3021376102, 3038613158, 3012062596, 3031841858, 3015442469, 3010626066, 3016975995, 3013053058, 3013561139, 3012759464, 3010834934, 3015200642, 3011800804, 3042823784, 3012684779, 3030978471, 1417592, 3008729914, 3016871906, 1419937, 3013684412, 3021544150, 3010334650, 3043515178, 3002297831 +74 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.