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FDA 510(k)

DRITRAINER

K-Number: K930005 · 1993-03-03

ApplicantLaborie Medical Technologies, Ltd.
Decision Date1993-03-03
Product CodeKPN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DRITRAINER 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 1993-03-03 under 510(k) number K930005. The device is classified under product code KPN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRITRAINER?

DRITRAINER is a medical device that received FDA 510(k) clearance on 1993-03-03. The listed applicant is Laborie Medical Technologies, Ltd.. The 510(k) number is K930005.

When did DRITRAINER receive FDA 510(k) clearance?

DRITRAINER received FDA 510(k) clearance on 1993-03-03, under 510(k) number K930005.

Who is the listed applicant for DRITRAINER?

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 DRITRAINER?

The FDA product code for DRITRAINER is KPN.

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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 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

View all 11 devices →

Related Devices (Code: KPN)

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.

K130951SIMSimavita Pty LimitedK971442HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5Humed, Inc.K971855POTTY PAL AND FOREVER-DRYDigital Applications, Inc.K962770UROSURGE ACUTRAINERPrinceton Regulatory Assoc.K962416DRYTIME FOR BLADDER CONTROL SILENTBio-Systems ResearchK955338DRYTIME FOR POTTY TRAININGHealth Sense Intl., 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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