510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Shenzhen Wisonic Medical Technology Co., Ltd.

Shenzhen Guangdong, CN

SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD. appears in FDA device records in Shenzhen Guangdong, CN. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 7 510(k) clearances for Shenzhen Wisonic Medical Technology Co., Ltd. between 2018 and 2023. The busiest year on record is 2018, with 3. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Shenzhen Wisonic Medical Technology Co., Ltd., by decision year
YearClearances
20183
20201
20212
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K230066Carnation series Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K211886Clivia series Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K210154Labat series Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K191347Paragon XHD Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound SystemIYNSubstantially Equivalent

Registered establishments

FDA registered establishments for Shenzhen Wisonic Medical Technology Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30143027213014302721SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.Building 9, Baiwang Creative Factory, No. 1051, Songbai Road, Xili Street, Nanshan District, 518055 Shenzhen,, Shenzhen Guangdong 518055 CN2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain