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FDA 510(k)

SODEM POWER SYSTEM

K-Number: K935567 · 1994-01-21

ApplicantSodemsystems
Decision Date1994-01-21
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SODEM POWER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sodemsystems. It received FDA 510(k) clearance on 1994-01-21 under 510(k) number K935567. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SODEM POWER SYSTEM?

SODEM POWER SYSTEM is a medical device that received FDA 510(k) clearance on 1994-01-21. The listed applicant is Sodemsystems. The 510(k) number is K935567.

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

SODEM POWER SYSTEM received FDA 510(k) clearance on 1994-01-21, under 510(k) number K935567.

Who is the listed applicant for SODEM POWER SYSTEM?

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

What is the FDA product code for SODEM POWER SYSTEM?

The FDA product code for SODEM POWER SYSTEM is HWE.

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Other records listing Sodemsystems 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.

K023070SODEM HIGH SPEED SYSTEM (PNEUMATIC)K023066DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)K012457SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)K012453SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)K012456SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)K993851SODEM PERFORATOR DRIVE

View all 8 devices →

Related Devices (Code: HWE)

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.

K102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESOrtho Solutions LimitedK063688SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBEThe Anspach Effort, Inc.K050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEMZimmer TrabecularK043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)K022744REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSMedical Device ServicesK012694REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSAdven Medical

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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