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SG Healthcare Co Ltd

Moga-myeon, Icheon-si Gyeonggi, KR

SG HEALTHCARE CO LTD appears in FDA device records in Moga-myeon, Icheon-si Gyeonggi, KR. FDA records list 3 510(k) clearances between and , no PMA records and 2 registered establishments. 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
2

510(k) clearance history

FDA records hold 3 510(k) clearances for SG Healthcare Co Ltd between 2015 and 2023. The busiest year on record is 2015, with 1. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for SG Healthcare Co Ltd, by decision year
YearClearances
20151
20221
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K230241Jumong GeneralKPRSubstantially Equivalent
K222080Garion Image-Intensified Fluoroscopic X-Ray System, MobileOWBSubstantially Equivalent
K150816Jumong SeriesKPRSubstantially Equivalent

Registered establishments

FDA registered establishments for SG Healthcare Co Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30097151363009715136SG HEALTHCARE CO LTD10, Yangnyeong-ro, Moga-myeon, Icheon-si Gyeonggi 17408 KR2026and 4 more, listed in full below
30116654703011665470SG Healthcare, Inc.2120 W 8th St Ste 305, Los Angeles, CA 90057 US2026No device listings on this registration

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