Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Airway Monitoring System
510(k) Number K193058
Device Name SonarMed AirWave Airway Monitoring System
Applicant
SonarMed, Inc.
12220 N. Meridian St., Ste. 150
Carmel,  IN  46032
Applicant Contact Laura Lyons
Correspondent
SonarMed, Inc.
12220 N. Meridian St., Ste. 150
Carmel,  IN  46032
Correspondent Contact Laura Lyons
Regulation Number868.5730
Classification Product Code
OQU  
Date Received11/01/2019
Decision Date 05/15/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-