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FDA 510(k)

LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY

K-Number: K073552 · 2008-03-05

ApplicantLaborie Medical Technologies, Corp.
Decision Date2008-03-05
Product CodeFEN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY is the device name listed in this FDA 510(k) record. The listed applicant is Laborie Medical Technologies, Corp.. It received FDA 510(k) clearance on 2008-03-05 under 510(k) number K073552. 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 LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY?

LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY is a medical device that received FDA 510(k) clearance on 2008-03-05. The listed applicant is Laborie Medical Technologies, Corp.. The 510(k) number is K073552.

When did LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY receive FDA 510(k) clearance?

LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY received FDA 510(k) clearance on 2008-03-05, under 510(k) number K073552.

Who is the listed applicant for LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY?

The FDA 510(k) record lists Laborie Medical Technologies, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY?

The FDA product code for LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY is FEN.

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Other records listing Laborie Medical Technologies, Corp. 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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