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FDA 510(k)

AUDICOR UPGRADE SYSTEM

K-Number: K032145 · 2003-10-31

ApplicantInovise Medical, Inc.
Decision Date2003-10-31
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AUDICOR UPGRADE SYSTEM 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 2003-10-31 under 510(k) number K032145. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDICOR UPGRADE SYSTEM?

AUDICOR UPGRADE SYSTEM is a medical device that received FDA 510(k) clearance on 2003-10-31. The listed applicant is Inovise Medical, Inc.. The 510(k) number is K032145.

When did AUDICOR UPGRADE SYSTEM receive FDA 510(k) clearance?

AUDICOR UPGRADE SYSTEM received FDA 510(k) clearance on 2003-10-31, under 510(k) number K032145.

Who is the listed applicant for AUDICOR UPGRADE SYSTEM?

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 UPGRADE SYSTEM?

The FDA product code for AUDICOR UPGRADE SYSTEM is DPS.

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Other records listing Inovise Medical, Inc. 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.

K151433AUDICOR CA300/CC100 Analyzer with SDBK130660AUDICOR CPAM WITH SDB (SINGLE SENSOR)K120462AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)K110569AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)K103516AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0K080602AUDICOR SENSOR, MODELS: 2.0, 3.0

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Related Devices (Code: DPS)

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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