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

Nishi-Tokyo-Shi, JP

CITIZEN SYSTEMS JAPAN CO., LTD. appears in FDA device records in Nishi-Tokyo-Shi, JP. FDA records list 4 510(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
4
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 4 510(k) clearances for Citizen Systems Japan Co., Ltd. in 2010.

Clearances by year, as a table
510(k) clearance decisions for Citizen Systems Japan Co., Ltd., by decision year
YearClearances
20104
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K102303BLOOD PRESSURE METER, MODEL CH-658DXNSubstantially Equivalent
K100055BLOOD PRESSURE METER, MODEL CH-609DXNSubstantially Equivalent
K093931BLOOD PRESSURE METER, MODEL CH-4532DXNSubstantially Equivalent
K100553BLOOD PRESSURE METER MODEL CH-101DXNSubstantially Equivalent

Registered establishments

FDA registered establishments for Citizen Systems Japan Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
80315093005176386CITIZEN SYSTEMS JAPAN CO., LTD.6-1-12, TANASHI-CHO, NISHI-TOKYO-SHI 188-8511 JP2026

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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What MDM checks, and what it does not

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