510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Sentech Korea Corp.

PAJU-SI Gyeonggi, KR

SENTECH KOREA CORP. appears in FDA device records in PAJU-SI Gyeonggi, KR. FDA records list 3 510(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
3
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Sentech Korea Corp. in 2006.

Clearances by year, as a table
510(k) clearance decisions for Sentech Korea Corp., by decision year
YearClearances
20063
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K061922BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000DJZSubstantially Equivalent
K060343BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000DJZSubstantially Equivalent
K053332BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500DJZSubstantially Equivalent

Registered establishments

FDA registered establishments for Sentech Korea Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30033838683003383868SENTECH KOREA CORP.21-6, Jimok-ro 75beon-gil, PAJU-SI Gyeonggi 10880 KR2026

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