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

SHIBUKAWA Gunma, JP

NIHON SEIMITSU SOKKI CO., LTD. appears in FDA device records in SHIBUKAWA Gunma, JP. 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 Nihon Seimitsu Sokki Co., Ltd. between 1985 and 2012. The busiest year on record is 1985, with 4. The most recent is 2012, with 3.

Clearances by year, as a table
510(k) clearance decisions for Nihon Seimitsu Sokki Co., Ltd., by decision year
YearClearances
19854
19881
19951
19992
20001
20011
20031
20041
20051
20061
20071
20082
20101
20123
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K112620DISITAL BLOOD PRESSURE MONITORDXNSubstantially Equivalent
K112691BLOOD PRESSURE MONITORDXNSubstantially Equivalent
K112690BLOOD PRESSURE MONITORDXNSubstantially Equivalent
K093102AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270DXNSubstantially Equivalent
K080177WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PVDXNSubstantially Equivalent
K071596POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7IRPSubstantially Equivalent
K071384MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901DXNSubstantially Equivalent
K061086DM-3000 DIGITAL BLOOD PRESSURE MONITORDXNSubstantially Equivalent
K050697MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITORDXNSubstantially Equivalent
K040309DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862DXNSubstantially Equivalent
K031582WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20MNWSubstantially Equivalent
K012194BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110DXQSubstantially Equivalent
K003444MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITORDXNSubstantially Equivalent
K993890DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-181DXNSubstantially Equivalent
K981702AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-300DXNSubstantially Equivalent
K952494DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITORDXNSubstantially Equivalent
K882635ELECTRONIC DIGITAL BLOOD PRESSURE MONITORDXNSubstantially Equivalent
K850318UNISONIC ELECTRONIC DIGITAL BP MONITOR EMB-4050DXNSubstantially Equivalent
K850317UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-3050DXNSubstantially Equivalent
K850316UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-2050DXNSubstantially Equivalent
K850315UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-1050DXNSubstantially Equivalent

Registered establishments

FDA registered establishments for Nihon Seimitsu Sokki Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
80100613002807736NIHON SEIMITSU SOKKI CO., LTD.2508-13 NAKAGO, SHIBUKAWA Gunma 377-0293 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

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