510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Grandway Technology (Shenzhen) Limited

Shenzhen Guangdong, CN

GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED appears in FDA device records in Shenzhen Guangdong, CN. FDA records list 21 510(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
21
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 21 510(k) clearances for Grandway Technology (Shenzhen) Limited between 2011 and 2019. The busiest year on record is 2015, with 7. The most recent is 2019, with 1.

Clearances by year, as a table
510(k) clearance decisions for Grandway Technology (Shenzhen) Limited, by decision year
YearClearances
20111
20134
20144
20157
20173
20181
20191
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K191593Digital Automatic Blood Pressure Monitor MD36 SeriesDXNSubstantially Equivalent
K171379Digital Automatic Wrist Blood Pressure Monitor MD4300DXNSubstantially Equivalent
K163648Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 SeriesDXNSubstantially Equivalent
K163679Digital Automatic Blood Pressure Monitor MD3600DXNSubstantially Equivalent
K163113Digital Automatic Wrist Blood Pressure Monitor SWBPM22 SeriesDXNSubstantially Equivalent
K152483Digital Automatic Blood Pressure Monitor BPM30 and BPM31 SeriesDXNSubstantially Equivalent
K151587Digital Automatic Wrist Blood Pressure Monitor MD3200DXNSubstantially Equivalent
K151583Digital Automatic Wrist Blood Pressure Monitor MD3900DXNSubstantially Equivalent
K143735Digital Automatic Blood Pressure Monitor MD2300DXNSubstantially Equivalent
K150373Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0]DXNSubstantially Equivalent
K143734Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810DXNSubstantially Equivalent
K143733Digital Automatic Wrist Blood Pressure Monitor MD2400DXNSubstantially Equivalent
K142088DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIESDXNSubstantially Equivalent
K140583DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIESDXNSubstantially Equivalent
K133619DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIESDXNSubstantially Equivalent
K133618DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIESDXNSubstantially Equivalent
K132240DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIESDXNSubstantially Equivalent
K123073DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0DXNSubstantially Equivalent
K120675DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIESDXNSubstantially Equivalent
K120673DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIESDXNSubstantially Equivalent
K110299DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIESDXNSubstantially Equivalent

Registered establishments

FDA registered establishments for Grandway Technology (Shenzhen) Limited, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30091559173009155917GRANDWAY TECHNOLOGY (SHENZHEN) LIMITEDNo. 5, the Second Industrial Zone, Zhukeng Community, Shenzhen Guangdong 518118 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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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