FDA 510(k)

QLVA PLUS

K-Number: K963859 · 1996-12-18

Decision Date1996-12-18

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

QLVA PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Sanders Data Systems, LLC. It received FDA 510(k) clearance on 1996-12-18 under 510(k) number K963859. 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 QLVA PLUS?

QLVA PLUS is a medical device that received FDA 510(k) clearance on 1996-12-18. The listed applicant is Sanders Data Systems, LLC. The 510(k) number is K963859.

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

QLVA PLUS received FDA 510(k) clearance on 1996-12-18, under 510(k) number K963859.

Who is the listed applicant for QLVA PLUS?

The FDA 510(k) record lists Sanders Data Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QLVA PLUS?

The FDA product code for QLVA PLUS is LLZ.

Other records listing Sanders Data Systems, LLC 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.

K915542QCA PLUS

Related Devices (Code: LLZ)

K261874Syneris PACS v.1.0.1.0Syneris K262442HipStudio AnalysisReplasia BV K261855Elucid 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.