510(k) clearances

Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)

Aoj Health Technology Co., Ltd. · Obstetrics/Gynecology

K233913Substantially EquivalentTraditionalHGX
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
Obstetrics/Gynecology
Address 1
Rm.302,Block A, Bldg. A, Jingfa Intelligentmanufacturing Par
Address 2
Xiaweiyuan, Gushu Community,Xixiang St., Bao'An District
Statement or summary
Statement
Product code
HGX
Zip code
518126
Applicant
Aoj Health Technology Co., Ltd.
Decision date
2024-05-14
Decision code
SESE
Country code
CN
Advisory committee
OB
Contact
Jack Wang
K number
K233913
Date received
2023-12-12
Review advisory committee
OB
Postal code
518126
Decision description
Substantially Equivalent
Clearance type
Traditional
Device name

Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)

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.