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FDA 510(k)

KENDALL PEDIATRIC URINE METER

K-Number: K911258 · 1991-04-25

ApplicantKendall Healthcare Products Co. Div.Of Tyco Health
Decision Date1991-04-25
Product CodeEXR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KENDALL PEDIATRIC URINE METER is the device name listed in this FDA 510(k) record. The listed applicant is Kendall Healthcare Products Co. Div.Of Tyco Health. It received FDA 510(k) clearance on 1991-04-25 under 510(k) number K911258. The device is classified under product code EXR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENDALL PEDIATRIC URINE METER?

KENDALL PEDIATRIC URINE METER is a medical device that received FDA 510(k) clearance on 1991-04-25. The listed applicant is Kendall Healthcare Products Co. Div.Of Tyco Health. The 510(k) number is K911258.

When did KENDALL PEDIATRIC URINE METER receive FDA 510(k) clearance?

KENDALL PEDIATRIC URINE METER received FDA 510(k) clearance on 1991-04-25, under 510(k) number K911258.

Who is the listed applicant for KENDALL PEDIATRIC URINE METER?

The FDA 510(k) record lists Kendall Healthcare Products Co. Div.Of Tyco Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KENDALL PEDIATRIC URINE METER?

The FDA product code for KENDALL PEDIATRIC URINE METER is EXR.

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Other records listing Kendall Healthcare Products Co. Div.Of Tyco Health 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.

K973763KENDALL CURITY IODOFORM PACKING STRIPK973511KENDALL CURITY PETROLATUM GAUZEK973507KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)K973619KENDALL CURITY NON-ADHERING DRESSINGK973509KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSINGK973546KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER

View all 66 devices →

Related Devices (Code: EXR)

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.

K934142URINARY DRAINAGE BAGKey Medical Services, Inc.K935578URINE METERPuritas Health Care, Inc.K896732UNOMETER 500Unoplast A/SK870240COMPRESS AND SKULLCAP, HEAD DRESSINGFraass Survival Systems, Inc.K771561DOVER URINE METERWill Ross Co.K770939URINE TESTER, MODEL 701Brother Scientific Products, 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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