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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 the device name listed in this FDA 510(k) record. The listed applicant is Inovise Medical, Inc.. It received FDA 510(k) clearance on 2016-03-18 under 510(k) 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. The listed applicant is Inovise Medical, Inc.. The 510(k) number is K151433.

When did AUDICOR CA300/CC100 Analyzer with SDB receive FDA 510(k) clearance?

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

Who is the listed applicant for AUDICOR CA300/CC100 Analyzer with SDB?

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

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.

Related Devices (Code: MNR)

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.

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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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