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FDA 510(k)

KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION

K-Number: K083598 · 2009-05-29

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2009-05-29
Product CodeODA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2009-05-29 under 510(k) number K083598. The device is classified under product code ODA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION?

KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION is a medical device that received FDA 510(k) clearance on 2009-05-29. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K083598.

When did KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION receive FDA 510(k) clearance?

KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION received FDA 510(k) clearance on 2009-05-29, under 510(k) number K083598.

Who is the listed applicant for KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION?

The FDA product code for KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION is ODA.

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Other records listing KARL STORZ Endoscopy-America, 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.

K252624KARL STORZ Laryngoscopes and AccessoriesK240506KARL STORZ HoldersK223885HOPKINS TelescopesK230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII SystemK223923HOPKINS Telescopes

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Related Devices (Code: ODA)

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.

K232406KARL STORZ OR1™ SCB CONTROL (WU300)Karl Storz SE & CO. KGK221929Smith+Nephew INTELLIO TabletSmith+NephewK203566Tablet ApplicationSmith & NephewK192876INTELLIO Tablet ApplicationSmith & NephewK153205IDSS ForceTriad Control ModuleBlack Diamond Video, Inc.K151282core nova Complete Operating Room EndoscopyRichard Wolf Medical Instruments Corp.

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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