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FDA 510(k)

EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG

K-Number: K192400 · 2019-10-03

ApplicantDRTECH Corporation
Decision Date2019-10-03
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG is the device name listed in this FDA 510(k) record. The listed applicant is DRTECH Corporation. It received FDA 510(k) clearance on 2019-10-03 under 510(k) number K192400. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG?

EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG is a medical device that received FDA 510(k) clearance on 2019-10-03. The listed applicant is DRTECH Corporation. The 510(k) number is K192400.

When did EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG receive FDA 510(k) clearance?

EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG received FDA 510(k) clearance on 2019-10-03, under 510(k) number K192400.

Who is the listed applicant for EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG?

The FDA 510(k) record lists DRTECH Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG?

The FDA product code for EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG is MQB.

Other records listing DRTECH Corporation 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.

K250010EXTRON 3; EXTRON 5; EXTRON 7K242770EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PGK243443EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NPK242591XERO-alphaK242847EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);K240243EConsole2

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Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

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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