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FDA 510(k)

ULTRASONIC SURGERY MACHINE

K-Number: K113152 · 2012-06-14

ApplicantDmetec.Co., Ltd.
Decision Date2012-06-14
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC SURGERY MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is Dmetec.Co., Ltd.. It received FDA 510(k) clearance on 2012-06-14 under 510(k) number K113152. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASONIC SURGERY MACHINE?

ULTRASONIC SURGERY MACHINE is a medical device that received FDA 510(k) clearance on 2012-06-14. The listed applicant is Dmetec.Co., Ltd.. The 510(k) number is K113152.

When did ULTRASONIC SURGERY MACHINE receive FDA 510(k) clearance?

ULTRASONIC SURGERY MACHINE received FDA 510(k) clearance on 2012-06-14, under 510(k) number K113152.

Who is the listed applicant for ULTRASONIC SURGERY MACHINE?

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

What is the FDA product code for ULTRASONIC SURGERY MACHINE?

The FDA product code for ULTRASONIC SURGERY MACHINE is DZI.

Related Clinical Trials

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Other records listing Dmetec.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.

K170104COMPACT S, COMPACT S (LED)K121620ULTRASONIC SURGERYK060171CLEANSE S+ ULTRASONIC SCALERK051571SKYLIGHT LED CURING LIGHT

Related Devices (Code: DZI)

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.

K253655Angled Screwdriver MED (M-SD090)W&H Dentalwerk Bürmoos GmbHK253776Implantmed Plus II & Piezomed Plus II ModuleW&H Dentalwerk Buermoos GmbHK254163VarioSurg 4Nakanishi, Inc.K242432MT-BoneMectron S.P.A.K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.K231087Guided Surgery KitImplant Direct Sybron Manufacturing, LLC

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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