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FDA 510(k)

BUZZY BEAR ENURESIS ALARM

K-Number: K895852 · 1990-02-12

ApplicantMed-Design, Inc.
Decision Date1990-02-12
Product CodeKPN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BUZZY BEAR ENURESIS ALARM is the device name listed in this FDA 510(k) record. The listed applicant is Med-Design, Inc.. It received FDA 510(k) clearance on 1990-02-12 under 510(k) number K895852. 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 BUZZY BEAR ENURESIS ALARM?

BUZZY BEAR ENURESIS ALARM is a medical device that received FDA 510(k) clearance on 1990-02-12. The listed applicant is Med-Design, Inc.. The 510(k) number is K895852.

When did BUZZY BEAR ENURESIS ALARM receive FDA 510(k) clearance?

BUZZY BEAR ENURESIS ALARM received FDA 510(k) clearance on 1990-02-12, under 510(k) number K895852.

Who is the listed applicant for BUZZY BEAR ENURESIS ALARM?

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

What is the FDA product code for BUZZY BEAR ENURESIS ALARM?

The FDA product code for BUZZY BEAR ENURESIS ALARM 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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