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FDA 510(k)

NIGHT TRAINER

K-Number: K834311 · 1984-03-30

ApplicantMaddak, Inc.
Decision Date1984-03-30
Product CodeKPN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NIGHT TRAINER is the device name listed in this FDA 510(k) record. The listed applicant is Maddak, Inc.. It received FDA 510(k) clearance on 1984-03-30 under 510(k) number K834311. 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 NIGHT TRAINER?

NIGHT TRAINER is a medical device that received FDA 510(k) clearance on 1984-03-30. The listed applicant is Maddak, Inc.. The 510(k) number is K834311.

When did NIGHT TRAINER receive FDA 510(k) clearance?

NIGHT TRAINER received FDA 510(k) clearance on 1984-03-30, under 510(k) number K834311.

Who is the listed applicant for NIGHT TRAINER?

The FDA 510(k) record lists Maddak, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIGHT TRAINER?

The FDA product code for NIGHT TRAINER is KPN.

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Other records listing Maddak, Inc. 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.

K841700WALK & ROLLK841695CRAWLERK841698HEAT PACKK841697HYDRO-THERO PADK841693STANDING FRAMEK841692PRONE STANDER

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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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