510(k) K193058
K193058 is an FDA 510(k) premarket notification submitted by Sonarmed, Inc. for the device "SonarMed AirWave Airway Monitoring System". The FDA issued a decision of Substantially Equivalent on May 15, 2020. The device falls under product code OQU (Airway Monitoring System), a Class II device regulated under 21 CFR 868.5730. Sonarmed, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 2020
- Date Received
- November 1, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Airway Monitoring System
- Device Class
- Class II
- Regulation Number
- 868.5730
- Review Panel
- AN
- Submission Type
The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip