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

San Jose, CA, US

Sejoy Electronics & Instruments Co., Ltd. appears in FDA device records in San Jose, CA. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
14
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 14 510(k) clearances for Sejoy Electronics & Instruments Co., Ltd. between 2006 and 2017. The busiest year on record is 2015, with 3. The most recent is 2017, with 1.

Clearances by year, as a table
510(k) clearance decisions for Sejoy Electronics & Instruments Co., Ltd., by decision year
YearClearances
20061
20071
20082
20111
20122
20141
20153
20162
20171
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K161577Arm-Type Fully Automatic Digital Blood Pressure MonitorDXNSubstantially Equivalent
K153149Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36FLLSubstantially Equivalent
K153146Infrared Ear ThermometerFLLSubstantially Equivalent
K152426Wrist - Type Fully Automatic Digital Blood Pressure MonitorDXNSubstantially Equivalent
K152687Arm-Type Fully Automatic Digital Blood Pressure MonitorDXNSubstantially Equivalent
K150545Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13)DXNSubstantially Equivalent
K141755ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITORDXNSubstantially Equivalent
K120554ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITORDXNSubstantially Equivalent
K121355WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITORDXNSubstantially Equivalent
K110776DIGITAL THERMOMETER MT SERIESFLLSubstantially Equivalent
K082192INFRARED EAR THERMOMETER, MODEL ET-101AFLLSubstantially Equivalent
K080789BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202DXNSubstantially Equivalent
K062784SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405)FLLSubstantially Equivalent
K051699SEJOY, MODEL MT-403FLLSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

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