510(k) K092611

Device: SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901
Applicant: SONARMED, INC.
510(k) number: K092611
Product code: OQU
Decision: Substantially Equivalent (SESE)
Decision date: 2010-04-28
Date received: 2009-08-26
Regulation: 868.5730
Classification name: Airway Monitoring System
Medical specialty: Anesthesiology
Review panel: Anesthesiology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: LAURA LYONS
Address: 5513 W. 74th St. Indianapolis IN US 46268 46268

FDA Registration Numbers#

2024500
3018094310

Source Documents#

Other 510(k) Records For Product Code OQU #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K193058	SonarMed AirWave Airway Monitoring System	Sonarmed, Inc.	2020-05-15
K143042	SonarMed AirWave, Airway Monitoring System	Sonarmed, Inc.	2016-01-22

Legacy Summary#

summary

FDA Review#

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