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FDA 510(k)

LUMIX 70B

K-Number: K951734 · 1995-07-20

ApplicantEmix U.S.A., Inc.
Decision Date1995-07-20
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LUMIX 70B is the device name listed in this FDA 510(k) record. The listed applicant is Emix U.S.A., Inc.. It received FDA 510(k) clearance on 1995-07-20 under 510(k) number K951734. The device is classified under product code EAP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMIX 70B?

LUMIX 70B is a medical device that received FDA 510(k) clearance on 1995-07-20. The listed applicant is Emix U.S.A., Inc.. The 510(k) number is K951734.

When did LUMIX 70B receive FDA 510(k) clearance?

LUMIX 70B received FDA 510(k) clearance on 1995-07-20, under 510(k) number K951734.

Who is the listed applicant for LUMIX 70B?

The FDA 510(k) record lists Emix U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUMIX 70B?

The FDA product code for LUMIX 70B is EAP.

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 Emix U.S.A., Inc. 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.

K940540VELO ACE

Related Devices (Code: EAP)

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.

K113360MEDICAL IMAGE PROCESSING UNITHumanray Co,LtdK102573PROVU (TM) DENTAL X-RAY SYSTEMAdvanced Image Science, Inc.K093453MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.K080738DENTRON SENSORDentron Systems, LLCK052422THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)Flow X-Ray Corp.K041385MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, 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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