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FDA 510(k)

AUDICOR CA300/CC100 Analyzer with SDB

K-Number: K151433 · 2016-03-18

ApplicantInovise Medical, Inc.
Decision Date2016-03-18
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUDICOR CA300/CC100 Analyzer with SDB is a medical device manufactured by Inovise Medical, Inc.. It received FDA 510(k) clearance on 2016-03-18 under approval number K151433. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDICOR CA300/CC100 Analyzer with SDB?

AUDICOR CA300/CC100 Analyzer with SDB is a medical device that received FDA 510(k) clearance on 2016-03-18. It is manufactured by Inovise Medical, Inc.. The 510(k) number is K151433.

When was AUDICOR CA300/CC100 Analyzer with SDB approved by the FDA?

AUDICOR CA300/CC100 Analyzer with SDB received FDA 510(k) clearance on 2016-03-18, under approval number K151433.

What company makes AUDICOR CA300/CC100 Analyzer with SDB?

AUDICOR CA300/CC100 Analyzer with SDB is manufactured by Inovise Medical, Inc..

What is the FDA product code for AUDICOR CA300/CC100 Analyzer with SDB?

The FDA product code for AUDICOR CA300/CC100 Analyzer with SDB is MNR.

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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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