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FDA 510(k)

SOFTVIEW, MODEL 2.01

K-Number: K092363 · 2010-03-18

ApplicantRiverain Medical Group
Decision Date2010-03-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOFTVIEW, MODEL 2.01 is the device name listed in this FDA 510(k) record. The listed applicant is Riverain Medical Group. It received FDA 510(k) clearance on 2010-03-18 under 510(k) number K092363. 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 SOFTVIEW, MODEL 2.01?

SOFTVIEW, MODEL 2.01 is a medical device that received FDA 510(k) clearance on 2010-03-18. The listed applicant is Riverain Medical Group. The 510(k) number is K092363.

When did SOFTVIEW, MODEL 2.01 receive FDA 510(k) clearance?

SOFTVIEW, MODEL 2.01 received FDA 510(k) clearance on 2010-03-18, under 510(k) number K092363.

Who is the listed applicant for SOFTVIEW, MODEL 2.01?

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

What is the FDA product code for SOFTVIEW, MODEL 2.01?

The FDA product code for SOFTVIEW, MODEL 2.01 is LLZ.

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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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