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FDA 510(k)

HEALTHSHIELD

K-Number: K885345 · 1989-05-24

ApplicantJonas, Inc.
Decision Date1989-05-24
Product CodeKPN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEALTHSHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Jonas, Inc.. It received FDA 510(k) clearance on 1989-05-24 under 510(k) number K885345. 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 HEALTHSHIELD?

HEALTHSHIELD is a medical device that received FDA 510(k) clearance on 1989-05-24. The listed applicant is Jonas, Inc.. The 510(k) number is K885345.

When did HEALTHSHIELD receive FDA 510(k) clearance?

HEALTHSHIELD received FDA 510(k) clearance on 1989-05-24, under 510(k) number K885345.

Who is the listed applicant for HEALTHSHIELD?

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

What is the FDA product code for HEALTHSHIELD?

The FDA product code for HEALTHSHIELD 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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