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FDA 510(k)

NYTONE ENURETIC ALARM BEDWETTING DEVICE

K-Number: K844866 · 1985-04-03

ApplicantNytone Medical
Decision Date1985-04-03
Product CodeKPN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NYTONE ENURETIC ALARM BEDWETTING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Nytone Medical. It received FDA 510(k) clearance on 1985-04-03 under 510(k) number K844866. 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 NYTONE ENURETIC ALARM BEDWETTING DEVICE?

NYTONE ENURETIC ALARM BEDWETTING DEVICE is a medical device that received FDA 510(k) clearance on 1985-04-03. The listed applicant is Nytone Medical. The 510(k) number is K844866.

When did NYTONE ENURETIC ALARM BEDWETTING DEVICE receive FDA 510(k) clearance?

NYTONE ENURETIC ALARM BEDWETTING DEVICE received FDA 510(k) clearance on 1985-04-03, under 510(k) number K844866.

Who is the listed applicant for NYTONE ENURETIC ALARM BEDWETTING DEVICE?

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

What is the FDA product code for NYTONE ENURETIC ALARM BEDWETTING DEVICE?

The FDA product code for NYTONE ENURETIC ALARM BEDWETTING DEVICE is KPN.

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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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