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FDA 510(k)

INSPIRSTAR GLOVE ELECTRODE

K-Number: K061343 · 2006-05-31

ApplicantInspirstar, Inc.
Decision Date2006-05-31
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INSPIRSTAR GLOVE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Inspirstar, Inc.. It received FDA 510(k) clearance on 2006-05-31 under 510(k) number K061343. 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 INSPIRSTAR GLOVE ELECTRODE?

INSPIRSTAR GLOVE ELECTRODE is a medical device that received FDA 510(k) clearance on 2006-05-31. The listed applicant is Inspirstar, Inc.. The 510(k) number is K061343.

When did INSPIRSTAR GLOVE ELECTRODE receive FDA 510(k) clearance?

INSPIRSTAR GLOVE ELECTRODE received FDA 510(k) clearance on 2006-05-31, under 510(k) number K061343.

Who is the listed applicant for INSPIRSTAR GLOVE ELECTRODE?

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

What is the FDA product code for INSPIRSTAR GLOVE ELECTRODE?

The FDA product code for INSPIRSTAR GLOVE ELECTRODE is GXY.

Related Clinical Trials

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Other records listing Inspirstar, 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.

K060368INSPIRSTAR IS02 MICROCURRENT STIMULATOR

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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