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FDA 510(k)

REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS

K-Number: K921504 · 1992-09-11

ApplicantChalgren Enterprises, Inc.
Decision Date1992-09-11
Product CodeJXE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS is the device name listed in this FDA 510(k) record. The listed applicant is Chalgren Enterprises, Inc.. It received FDA 510(k) clearance on 1992-09-11 under 510(k) number K921504. The device is classified under product code JXE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS?

REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS is a medical device that received FDA 510(k) clearance on 1992-09-11. The listed applicant is Chalgren Enterprises, Inc.. The 510(k) number is K921504.

When did REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS receive FDA 510(k) clearance?

REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS received FDA 510(k) clearance on 1992-09-11, under 510(k) number K921504.

Who is the listed applicant for REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS?

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

What is the FDA product code for REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS?

The FDA product code for REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS is JXE.

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Other records listing Chalgren Enterprises, 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.

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Related Devices (Code: JXE)

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K240189NM-01/CPT neurometer (NM-01/CPT)Mde Orvosbiológiai Kutató, Fejleszto,K190536Mediracer NCSMediracer OYK070109NEUROMETRIX ADVANCENeurometrix, Inc.K060584NC-STATNeurometrix, Inc.K053058XLTEK NEUROPATH, MODEL PK1070Excel Tech. , Ltd.K052904VIRTUAL MEDICAL SYSTEMS MODEL VT3000Scientific Imaging, 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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