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FDA 510(k)

AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)

K-Number: K120462 · 2012-09-20

ApplicantInovise Medical, Inc.
Decision Date2012-09-20
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) 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 2012-09-20 under 510(k) number K120462. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)?

AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) is a medical device that received FDA 510(k) clearance on 2012-09-20. The listed applicant is Inovise Medical, Inc.. The 510(k) number is K120462.

When did AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) receive FDA 510(k) clearance?

AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) received FDA 510(k) clearance on 2012-09-20, under 510(k) number K120462.

Who is the listed applicant for AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)?

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 CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)?

The FDA product code for AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) is MLO.

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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)K110569AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)K103516AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0K080602AUDICOR SENSOR, MODELS: 2.0, 3.0K073545AUDICOR, HEMO AMBULATORY MONITOR

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Related Devices (Code: MLO)

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.

K261580ZBPro Diagnostic (Version 2.0)Zbeats, Inc.K241890Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbHK240794Frontier X PlusFourth Frontier Technologies Pvt, Ltd.K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.K193177CER-SCardiocalmK182030Faros MobileBittium Biosignals , Ltd.

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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