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FDA 510(k)

GUARDIAN 150 ELECTRODE

K-Number: K083756 · 2009-06-26

ApplicantSelectivemed Components, Inc.
Decision Date2009-06-26
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GUARDIAN 150 ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Selectivemed Components, Inc.. It received FDA 510(k) clearance on 2009-06-26 under 510(k) number K083756. 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 GUARDIAN 150 ELECTRODE?

GUARDIAN 150 ELECTRODE is a medical device that received FDA 510(k) clearance on 2009-06-26. The listed applicant is Selectivemed Components, Inc.. The 510(k) number is K083756.

When did GUARDIAN 150 ELECTRODE receive FDA 510(k) clearance?

GUARDIAN 150 ELECTRODE received FDA 510(k) clearance on 2009-06-26, under 510(k) number K083756.

Who is the listed applicant for GUARDIAN 150 ELECTRODE?

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

What is the FDA product code for GUARDIAN 150 ELECTRODE?

The FDA product code for GUARDIAN 150 ELECTRODE is GXY.

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Other records listing Selectivemed Components, 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.

K120922GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNITK031053SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7K020476MEDION 6000K993081IO-DRIVEK946230ENDURA REUSABLE TENS AND NMES ELECTRODESK945676GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES

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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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