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FDA 510(k)

SODEM HIGH SPEED SYSTEM

K-Number: K954080 · 1995-10-16

ApplicantSodem Diffusion SA
Decision Date1995-10-16
Product CodeHSZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SODEM HIGH SPEED SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sodem Diffusion SA. It received FDA 510(k) clearance on 1995-10-16 under 510(k) number K954080. The device is classified under product code HSZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SODEM HIGH SPEED SYSTEM?

SODEM HIGH SPEED SYSTEM is a medical device that received FDA 510(k) clearance on 1995-10-16. The listed applicant is Sodem Diffusion SA. The 510(k) number is K954080.

When did SODEM HIGH SPEED SYSTEM receive FDA 510(k) clearance?

SODEM HIGH SPEED SYSTEM received FDA 510(k) clearance on 1995-10-16, under 510(k) number K954080.

Who is the listed applicant for SODEM HIGH SPEED SYSTEM?

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

What is the FDA product code for SODEM HIGH SPEED SYSTEM?

The FDA product code for SODEM HIGH SPEED SYSTEM is HSZ.

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 Sodem Diffusion SA 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.

K954717SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMYK955174SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY

Related Devices (Code: HSZ)

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.

K991588EMS SWISS ORTHOCLAST(Ems Sa) Electro Medical SystemsK972860CURVTEK TSR SYSTEMBiolectron, Inc.K970345ALIGNMENT INSTRUMENTRichard Wolf Medical Instruments Corp.K955084ASPACH 65,000 (MODIFICATION)The Anspach Effort, Inc.K944590ETHICON DRILL BIT AND DRILL GUIDEETHICON, Inc.K934336SPINALPLANESynvasive Technology, Inc.

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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