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FDA 510(k)

ES-100 ACCESSORIES

K-Number: K932261 · 1994-01-07

ApplicantElekta Instruments, Inc.
Decision Date1994-01-07
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ES-100 ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Instruments, Inc.. It received FDA 510(k) clearance on 1994-01-07 under 510(k) number K932261. 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 ES-100 ACCESSORIES?

ES-100 ACCESSORIES is a medical device that received FDA 510(k) clearance on 1994-01-07. The listed applicant is Elekta Instruments, Inc.. The 510(k) number is K932261.

When did ES-100 ACCESSORIES receive FDA 510(k) clearance?

ES-100 ACCESSORIES received FDA 510(k) clearance on 1994-01-07, under 510(k) number K932261.

Who is the listed applicant for ES-100 ACCESSORIES?

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

What is the FDA product code for ES-100 ACCESSORIES?

The FDA product code for ES-100 ACCESSORIES is HWE.

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Other records listing Elekta Instruments, 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.

K983678ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLEK955064SPETZLER TI 100 ANEURYSM CLIPK941823LEKSELL NEURO GENERATOR AND ACCESSORIESK946165CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEMK943468LEKSELL SURGIPLANK925360ES-100 POWER SYSTEM, ES-100 SERIES

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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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