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FDA 510(k)

INFUSION PUMP, MODEL NO. UDP-5

K-Number: K942023 · 1994-07-12

ApplicantLaborie Medical Technologies, Ltd.
Decision Date1994-07-12
Product CodeFEN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INFUSION PUMP, MODEL NO. UDP-5 is the device name listed in this FDA 510(k) record. The listed applicant is Laborie Medical Technologies, Ltd.. It received FDA 510(k) clearance on 1994-07-12 under 510(k) number K942023. 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 INFUSION PUMP, MODEL NO. UDP-5?

INFUSION PUMP, MODEL NO. UDP-5 is a medical device that received FDA 510(k) clearance on 1994-07-12. The listed applicant is Laborie Medical Technologies, Ltd.. The 510(k) number is K942023.

When did INFUSION PUMP, MODEL NO. UDP-5 receive FDA 510(k) clearance?

INFUSION PUMP, MODEL NO. UDP-5 received FDA 510(k) clearance on 1994-07-12, under 510(k) number K942023.

Who is the listed applicant for INFUSION PUMP, MODEL NO. UDP-5?

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

What is the FDA product code for INFUSION PUMP, MODEL NO. UDP-5?

The FDA product code for INFUSION PUMP, MODEL NO. UDP-5 is FEN.

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Other records listing Laborie Medical Technologies, Ltd. 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.

K090830LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIPK962009UROSTYMK955856TEX-AID BLUEK955810U-TEXK951805PIPER, MODEL NUMBER UDS-PIPERBK942563ELITE BIOFEEDBACK

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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.

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

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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