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

Zhongshan Guangdong, CN

Zhongshan Transtek Electronics Co., Ltd appears in FDA device records in Zhongshan Guangdong, CN. FDA records list 9 510(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
9
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 9 510(k) clearances for Zhongshan Transtek Electronics Co., Ltd between 2011 and 2013. The busiest year on record is 2012, with 4. The most recent is 2013, with 2.

Clearances by year, as a table
510(k) clearance decisions for Zhongshan Transtek Electronics Co., Ltd, by decision year
YearClearances
20113
20124
20132
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K123780TRANSTEK BLOOD PRESSURE MONITORDXNSubstantially Equivalent
K123781TRANSTEK GLASS BODY FAT ANALYZERMNWSubstantially Equivalent
K123669TRANSTEK WRIST BLOOD PRESSURE MONITORDXNSubstantially Equivalent
K122482TRANSTEK WRIST BLOOD PRESSURE MONITORDXNSubstantially Equivalent
K121971WITHINGS, SMART BODY SCALEMNWSubstantially Equivalent
K120058TRANSTEK BLOOD PRESSURE MONITORDXNSubstantially Equivalent
K112932TRANSTEKMNWSubstantially Equivalent
K101681TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995DXNSubstantially Equivalent
K102191TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZERMNWSubstantially Equivalent

Registered establishments

FDA registered establishments for Zhongshan Transtek Electronics Co., Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30084853703008485370Zhongshan Transtek Electronics Co., LtdZone E, No. 105, Dongli Road, Zhongshan Guangdong 528437 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