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FDA 510(k)

UROTRACK PLUS

K-Number: K832526 · 1983-09-19

ApplicantVital Metrics, Inc.
Decision Date1983-09-19
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROTRACK PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Vital Metrics, Inc.. It received FDA 510(k) clearance on 1983-09-19 under 510(k) number K832526. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROTRACK PLUS?

UROTRACK PLUS is a medical device that received FDA 510(k) clearance on 1983-09-19. The listed applicant is Vital Metrics, Inc.. The 510(k) number is K832526.

When did UROTRACK PLUS receive FDA 510(k) clearance?

UROTRACK PLUS received FDA 510(k) clearance on 1983-09-19, under 510(k) number K832526.

Who is the listed applicant for UROTRACK PLUS?

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

What is the FDA product code for UROTRACK PLUS?

The FDA product code for UROTRACK PLUS is KNX.

Related Clinical Trials

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.

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Other records listing Vital Metrics, Inc. 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.

K883201VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYSK882956VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATIONK844973IRRIGA SUC ILLUM ISIS 710 & 7100 SERIESK843442URINARY DRAINAGE CONTAINER 2013 WITHK843441URINARY DRAINAGE CONTAINER 2012-WITHK840917URINARY MONITORING SYS 240

View all 9 devices →

Related Devices (Code: KNX)

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.

K110518IBAGFuture Path Medical, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, 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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