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FDA 510(k)

ELECTROLINK

K-Number: K920674 · 1993-01-28

ApplicantKold Products
Decision Date1993-01-28
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELECTROLINK is the device name listed in this FDA 510(k) record. The listed applicant is Kold Products. It received FDA 510(k) clearance on 1993-01-28 under 510(k) number K920674. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROLINK?

ELECTROLINK is a medical device that received FDA 510(k) clearance on 1993-01-28. The listed applicant is Kold Products. The 510(k) number is K920674.

When did ELECTROLINK receive FDA 510(k) clearance?

ELECTROLINK received FDA 510(k) clearance on 1993-01-28, under 510(k) number K920674.

Who is the listed applicant for ELECTROLINK?

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

What is the FDA product code for ELECTROLINK?

The FDA product code for ELECTROLINK is GXY.

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.

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Other records listing Kold Products 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.

K920554KOLD WRAP STERILE BURN DRESSING

Related Devices (Code: GXY)

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.

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,LtdK260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR Conditional Cup ElectrodesTechnomed Europe

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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