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FDA 510(k)

CART, MODE NUMBER UDS-CART

K-Number: K950016 · 1995-03-30

ApplicantLaborie Medical Tech Corp.
Decision Date1995-03-30
Product CodeFEN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CART, MODE NUMBER UDS-CART is the device name listed in this FDA 510(k) record. The listed applicant is Laborie Medical Tech Corp.. It received FDA 510(k) clearance on 1995-03-30 under 510(k) number K950016. 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 CART, MODE NUMBER UDS-CART?

CART, MODE NUMBER UDS-CART is a medical device that received FDA 510(k) clearance on 1995-03-30. The listed applicant is Laborie Medical Tech Corp.. The 510(k) number is K950016.

When did CART, MODE NUMBER UDS-CART receive FDA 510(k) clearance?

CART, MODE NUMBER UDS-CART received FDA 510(k) clearance on 1995-03-30, under 510(k) number K950016.

Who is the listed applicant for CART, MODE NUMBER UDS-CART?

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

What is the FDA product code for CART, MODE NUMBER UDS-CART?

The FDA product code for CART, MODE NUMBER UDS-CART is FEN.

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 Laborie Medical Tech Corp. 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.

K993721UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBESK990041UROSTYM BIOFEEDBACK AND STIMULATION PROBESK991479VISER PENILE TUMESCENCE MONITORK963064ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM

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.

K212830CT3000ProSrs MedicalK082701URONIRS, MODEL 2000Urodynamix Technologies, Ltd.K073552LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORYLaborie Medical Technologies, Corp.K001386ACCUSET SENSOR, MODEL 2000Pelvicare, Inc.K992715NEURO URODYNAMIC SUITE, MODEL 9032E0101Medtronic Functional Diagnostics A/SK983325IN-PROBE II URODYNAMIC SYSTEMInfluence, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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