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FDA 510(k)

DRI SLEEPER

K-Number: K934369 · 1993-11-24

ApplicantLaborie Medical Technologies, Ltd.
Decision Date1993-11-24
Product CodeKPN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DRI SLEEPER 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 1993-11-24 under 510(k) number K934369. 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 DRI SLEEPER?

DRI SLEEPER is a medical device that received FDA 510(k) clearance on 1993-11-24. The listed applicant is Laborie Medical Technologies, Ltd.. The 510(k) number is K934369.

When did DRI SLEEPER receive FDA 510(k) clearance?

DRI SLEEPER received FDA 510(k) clearance on 1993-11-24, under 510(k) number K934369.

Who is the listed applicant for DRI SLEEPER?

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 DRI SLEEPER?

The FDA product code for DRI SLEEPER is KPN.

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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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