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FDA 510(k)

XGEO GC80

K-Number: K123098 · 2013-01-18

ApplicantSamsung Electronics Co., Ltd.
Decision Date2013-01-18
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XGEO GC80 is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2013-01-18 under 510(k) number K123098. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XGEO GC80?

XGEO GC80 is a medical device that received FDA 510(k) clearance on 2013-01-18. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K123098.

When did XGEO GC80 receive FDA 510(k) clearance?

XGEO GC80 received FDA 510(k) clearance on 2013-01-18, under 510(k) number K123098.

Who is the listed applicant for XGEO GC80?

The FDA 510(k) record lists Samsung Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XGEO GC80?

The FDA product code for XGEO GC80 is KPR.

Other records listing Samsung Electronics Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260481GC85AK261187Hearing Aid FeatureK261011Sleep Apnea Feature (v2.0)K242651GM85K242478GF85 (models GF85-3P, GF85-SP)K240909Samsung ECG App v 1.3 (ECG)

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Related Devices (Code: KPR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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