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FDA 510(k)

NEURO URODYNAMIC SUITE, MODEL 9032E0101

K-Number: K992715 · 2000-02-28

ApplicantMedtronic Functional Diagnostics A/S
Decision Date2000-02-28
Product CodeFEN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEURO URODYNAMIC SUITE, MODEL 9032E0101 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Functional Diagnostics A/S. It received FDA 510(k) clearance on 2000-02-28 under 510(k) number K992715. The device is classified under product code FEN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEURO URODYNAMIC SUITE, MODEL 9032E0101?

NEURO URODYNAMIC SUITE, MODEL 9032E0101 is a medical device that received FDA 510(k) clearance on 2000-02-28. The listed applicant is Medtronic Functional Diagnostics A/S. The 510(k) number is K992715.

When did NEURO URODYNAMIC SUITE, MODEL 9032E0101 receive FDA 510(k) clearance?

NEURO URODYNAMIC SUITE, MODEL 9032E0101 received FDA 510(k) clearance on 2000-02-28, under 510(k) number K992715.

Who is the listed applicant for NEURO URODYNAMIC SUITE, MODEL 9032E0101?

The FDA 510(k) record lists Medtronic Functional Diagnostics A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEURO URODYNAMIC SUITE, MODEL 9032E0101?

The FDA product code for NEURO URODYNAMIC SUITE, MODEL 9032E0101 is FEN.

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Other records listing Medtronic Functional Diagnostics A/S as applicant

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Related Devices (Code: FEN)

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

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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