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FDA 510(k)

GLOBALCARE ELECTRODE

K-Number: K913373 · 1991-08-29

ApplicantGlobalcare Intl., Inc.
Decision Date1991-08-29
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GLOBALCARE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Globalcare Intl., Inc.. It received FDA 510(k) clearance on 1991-08-29 under 510(k) number K913373. 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 GLOBALCARE ELECTRODE?

GLOBALCARE ELECTRODE is a medical device that received FDA 510(k) clearance on 1991-08-29. The listed applicant is Globalcare Intl., Inc.. The 510(k) number is K913373.

When did GLOBALCARE ELECTRODE receive FDA 510(k) clearance?

GLOBALCARE ELECTRODE received FDA 510(k) clearance on 1991-08-29, under 510(k) number K913373.

Who is the listed applicant for GLOBALCARE ELECTRODE?

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

What is the FDA product code for GLOBALCARE ELECTRODE?

The FDA product code for GLOBALCARE ELECTRODE 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 Globalcare Intl., 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.

K913444GLOBALCARE EMSK910244GLOBAL CARE MICRO IIK903394GLOBALCARE MICRO 11 AND MICROCARE (TENS)

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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