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FDA 510(k)

SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901

K-Number: K092611 · 2010-04-28

ApplicantSonarmed, Inc.
Decision Date2010-04-28
Product CodeOQU
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 is the device name listed in this FDA 510(k) record. The listed applicant is Sonarmed, Inc.. It received FDA 510(k) clearance on 2010-04-28 under 510(k) number K092611. The device is classified under product code OQU. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901?

SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 is a medical device that received FDA 510(k) clearance on 2010-04-28. The listed applicant is Sonarmed, Inc.. The 510(k) number is K092611.

When did SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 receive FDA 510(k) clearance?

SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 received FDA 510(k) clearance on 2010-04-28, under 510(k) number K092611.

Who is the listed applicant for SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901?

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

What is the FDA product code for SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901?

The FDA product code for SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 is OQU.

Related Clinical Trials

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Other records listing Sonarmed, 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.

K193058SonarMed AirWave Airway Monitoring SystemK143042SonarMed AirWave, Airway Monitoring System

Related Devices (Code: OQU)

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.

K193058SonarMed AirWave Airway Monitoring SystemSonarmed, Inc.K143042SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc.

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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