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FDA 510(k)

MONITORING DEVICE ENURESIS ALARM & ACC.

K-Number: K821546 · 1982-06-09

ApplicantWetbell, Inc.
Decision Date1982-06-09
Product CodeKPN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MONITORING DEVICE ENURESIS ALARM & ACC. is the device name listed in this FDA 510(k) record. The listed applicant is Wetbell, Inc.. It received FDA 510(k) clearance on 1982-06-09 under 510(k) number K821546. 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 MONITORING DEVICE ENURESIS ALARM & ACC.?

MONITORING DEVICE ENURESIS ALARM & ACC. is a medical device that received FDA 510(k) clearance on 1982-06-09. The listed applicant is Wetbell, Inc.. The 510(k) number is K821546.

When did MONITORING DEVICE ENURESIS ALARM & ACC. receive FDA 510(k) clearance?

MONITORING DEVICE ENURESIS ALARM & ACC. received FDA 510(k) clearance on 1982-06-09, under 510(k) number K821546.

Who is the listed applicant for MONITORING DEVICE ENURESIS ALARM & ACC.?

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

What is the FDA product code for MONITORING DEVICE ENURESIS ALARM & ACC.?

The FDA product code for MONITORING DEVICE ENURESIS ALARM & ACC. 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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