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FDA 510(k)

PROCEDURE REHEARSAL STUDIO

K-Number: K093269 · 2010-08-20

ApplicantSimbionix , Ltd.
Decision Date2010-08-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROCEDURE REHEARSAL STUDIO is the device name listed in this FDA 510(k) record. The listed applicant is Simbionix , Ltd.. It received FDA 510(k) clearance on 2010-08-20 under 510(k) number K093269. 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 PROCEDURE REHEARSAL STUDIO?

PROCEDURE REHEARSAL STUDIO is a medical device that received FDA 510(k) clearance on 2010-08-20. The listed applicant is Simbionix , Ltd.. The 510(k) number is K093269.

When did PROCEDURE REHEARSAL STUDIO receive FDA 510(k) clearance?

PROCEDURE REHEARSAL STUDIO received FDA 510(k) clearance on 2010-08-20, under 510(k) number K093269.

Who is the listed applicant for PROCEDURE REHEARSAL STUDIO?

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

What is the FDA product code for PROCEDURE REHEARSAL STUDIO?

The FDA product code for PROCEDURE REHEARSAL STUDIO is LLZ.

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Other records listing Simbionix , Ltd. 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.

K123269PROCEDURE REHEARSAL STUDIOK112387PROCEDURE REHEARSAL STUDIO(TM)

Related Devices (Code: LLZ)

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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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