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FDA 510(k)

UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1

K-Number: K083679 · 2009-09-11

ApplicantUroval
Decision Date2009-09-11
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 is the device name listed in this FDA 510(k) record. The listed applicant is Uroval. It received FDA 510(k) clearance on 2009-09-11 under 510(k) number K083679. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1?

UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 is a medical device that received FDA 510(k) clearance on 2009-09-11. The listed applicant is Uroval. The 510(k) number is K083679.

When did UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 receive FDA 510(k) clearance?

UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 received FDA 510(k) clearance on 2009-09-11, under 510(k) number K083679.

Who is the listed applicant for UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1?

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

What is the FDA product code for UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1?

The FDA product code for UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 is IKN.

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Related Devices (Code: IKN)

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.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, 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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