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FDA 510(k)

INDICATENS INDICATOR ELECTRODE MODEL 2

K-Number: K891107 · 1989-05-25

ApplicantAcudata Software
Decision Date1989-05-25
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INDICATENS INDICATOR ELECTRODE MODEL 2 is the device name listed in this FDA 510(k) record. The listed applicant is Acudata Software. It received FDA 510(k) clearance on 1989-05-25 under 510(k) number K891107. 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 INDICATENS INDICATOR ELECTRODE MODEL 2?

INDICATENS INDICATOR ELECTRODE MODEL 2 is a medical device that received FDA 510(k) clearance on 1989-05-25. The listed applicant is Acudata Software. The 510(k) number is K891107.

When did INDICATENS INDICATOR ELECTRODE MODEL 2 receive FDA 510(k) clearance?

INDICATENS INDICATOR ELECTRODE MODEL 2 received FDA 510(k) clearance on 1989-05-25, under 510(k) number K891107.

Who is the listed applicant for INDICATENS INDICATOR ELECTRODE MODEL 2?

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

What is the FDA product code for INDICATENS INDICATOR ELECTRODE MODEL 2?

The FDA product code for INDICATENS INDICATOR ELECTRODE MODEL 2 is GXY.

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Other records listing Acudata Software 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.

K900668ACUDATA INDICATENS MODEL 5XSK900596ACUDATA INDICATENS MODEL 5AK890087ACUDATA INDICATENS MODEL 5MK890088ACUDATA INDICATENS MODEL 5XK891105INDICATENS MODEL 4X4 SP ELECTRODE STIM. PATCHESK881708INDICATENS 4X4

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Related Devices (Code: GXY)

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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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