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FDA 510(k)

AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0

K-Number: K103516 · 2011-02-04

ApplicantInovise Medical, Inc.
Decision Date2011-02-04
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 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 2011-02-04 under 510(k) number K103516. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0?

AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 is a medical device that received FDA 510(k) clearance on 2011-02-04. The listed applicant is Inovise Medical, Inc.. The 510(k) number is K103516.

When did AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 receive FDA 510(k) clearance?

AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 received FDA 510(k) clearance on 2011-02-04, under 510(k) number K103516.

Who is the listed applicant for AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0?

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-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0?

The FDA product code for AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 is DQD.

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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)K080602AUDICOR SENSOR, MODELS: 2.0, 3.0K073545AUDICOR, HEMO AMBULATORY MONITOR

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Related Devices (Code: DQD)

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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