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FDA 510(k)

MEDART 620

K-Number: K120573 · 2012-06-13

ApplicantMedart A/S
Decision Date2012-06-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDART 620 is the device name listed in this FDA 510(k) record. The listed applicant is Medart A/S. It received FDA 510(k) clearance on 2012-06-13 under 510(k) number K120573. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDART 620?

MEDART 620 is a medical device that received FDA 510(k) clearance on 2012-06-13. The listed applicant is Medart A/S. The 510(k) number is K120573.

When did MEDART 620 receive FDA 510(k) clearance?

MEDART 620 received FDA 510(k) clearance on 2012-06-13, under 510(k) number K120573.

Who is the listed applicant for MEDART 620?

The FDA 510(k) record lists Medart A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDART 620?

The FDA product code for MEDART 620 is GEX. This falls under the Gastroenterology category.

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Other records listing Medart A/S 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.

K110243MEDART DIODE LASER SYSTEM & ACCESSORIESK083123MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES

Related Devices (Code: GEX)

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.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

Official Source

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

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