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FDA 510(k)

PORT OPII, PORT OPIII

K-Number: K923354 · 1993-10-05

ApplicantMobile Dental Equipment Corp.
Decision Date1993-10-05
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PORT OPII, PORT OPIII is the device name listed in this FDA 510(k) record. The listed applicant is Mobile Dental Equipment Corp.. It received FDA 510(k) clearance on 1993-10-05 under 510(k) number K923354. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORT OPII, PORT OPIII?

PORT OPII, PORT OPIII is a medical device that received FDA 510(k) clearance on 1993-10-05. The listed applicant is Mobile Dental Equipment Corp.. The 510(k) number is K923354.

When did PORT OPII, PORT OPIII receive FDA 510(k) clearance?

PORT OPII, PORT OPIII received FDA 510(k) clearance on 1993-10-05, under 510(k) number K923354.

Who is the listed applicant for PORT OPII, PORT OPIII?

The FDA 510(k) record lists Mobile Dental Equipment Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORT OPII, PORT OPIII?

The FDA product code for PORT OPII, PORT OPIII is EIA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mobile Dental Equipment Corp. 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.

K923359PORT-XPK923360PORT-XD

Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

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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