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FDA 510(k)

ULTRAEXTEND USWS-900A

K-Number: K082596 · 2008-09-23

ApplicantToshiba America Medical Systems, In.C
Decision Date2008-09-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRAEXTEND USWS-900A is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Medical Systems, In.C. It received FDA 510(k) clearance on 2008-09-23 under 510(k) number K082596. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAEXTEND USWS-900A?

ULTRAEXTEND USWS-900A is a medical device that received FDA 510(k) clearance on 2008-09-23. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K082596.

When did ULTRAEXTEND USWS-900A receive FDA 510(k) clearance?

ULTRAEXTEND USWS-900A received FDA 510(k) clearance on 2008-09-23, under 510(k) number K082596.

Who is the listed applicant for ULTRAEXTEND USWS-900A?

The FDA 510(k) record lists Toshiba America Medical Systems, In.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRAEXTEND USWS-900A?

The FDA product code for ULTRAEXTEND USWS-900A is LLZ.

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Other records listing Toshiba America Medical Systems, In.C 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.

K132106INFINIX ANGIO WORKSTATION W/DTS SOFTWAREK131822ULTRAEXTEND USWS-900A V2.1 AND V3.1K123097DOSE TRACKING SYSTEM MODEL XIDF-DTS801K122613VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/USK121076ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGEK122842RADREX-I, SW V4.00 MODEL DRAD-3000E

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Related Devices (Code: LLZ)

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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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