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FDA 510(k)

AUDICOR SENSOR, MODELS: 2.0, 3.0

K-Number: K080602 · 2008-09-25

ApplicantInovise Medical, Inc.
Decision Date2008-09-25
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AUDICOR SENSOR, MODELS: 2.0, 3.0 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 2008-09-25 under 510(k) number K080602. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDICOR SENSOR, MODELS: 2.0, 3.0?

AUDICOR SENSOR, MODELS: 2.0, 3.0 is a medical device that received FDA 510(k) clearance on 2008-09-25. The listed applicant is Inovise Medical, Inc.. The 510(k) number is K080602.

When did AUDICOR SENSOR, MODELS: 2.0, 3.0 receive FDA 510(k) clearance?

AUDICOR SENSOR, MODELS: 2.0, 3.0 received FDA 510(k) clearance on 2008-09-25, under 510(k) number K080602.

Who is the listed applicant for AUDICOR SENSOR, MODELS: 2.0, 3.0?

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 SENSOR, MODELS: 2.0, 3.0?

The FDA product code for AUDICOR SENSOR, MODELS: 2.0, 3.0 is DRX.

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Other records listing Inovise Medical, Inc. as applicant

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Related Devices (Code: DRX)

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

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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