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FDA 510(k)

SLE ELECTRODES AND ACCESSORIES

K-Number: K980410 · 1998-10-22

ApplicantSpecialized Laboratory Equipment, Ltd.
Decision Date1998-10-22
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SLE ELECTRODES AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Specialized Laboratory Equipment, Ltd.. It received FDA 510(k) clearance on 1998-10-22 under 510(k) number K980410. 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 SLE ELECTRODES AND ACCESSORIES?

SLE ELECTRODES AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1998-10-22. The listed applicant is Specialized Laboratory Equipment, Ltd.. The 510(k) number is K980410.

When did SLE ELECTRODES AND ACCESSORIES receive FDA 510(k) clearance?

SLE ELECTRODES AND ACCESSORIES received FDA 510(k) clearance on 1998-10-22, under 510(k) number K980410.

Who is the listed applicant for SLE ELECTRODES AND ACCESSORIES?

The FDA 510(k) record lists Specialized Laboratory Equipment, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLE ELECTRODES AND ACCESSORIES?

The FDA product code for SLE ELECTRODES AND ACCESSORIES 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 Specialized Laboratory Equipment, Ltd. 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.

K981004SLE EMG ELECTRODES AND ACCESSORIES

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.

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Official Source

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