SonarMed AirWave Airway Monitoring System— 510(k) K193058
Substantially EquivalentSonarmed, Inc.
FDA 510(k) clearance K193058 for SonarMed AirWave Airway Monitoring System, Substantially Equivalent on 2020-05-15. Applicant: Sonarmed, Inc.. Device class: 2.
Clearance details
- Applicant
- Sonarmed, Inc.
- Product code
- Code OQU
- Device class
- Class 2
- Regulation
- 21 CFR 868.5730
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carmel, IN, US
Recent devices under product code OQU
view allRecalls naming K193058
K-number listed on FDA's recall record- Z-1535-2024 — AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
- Z-1519-2024 — AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
- Z-1520-2024 — AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
- Z-1521-2024 — AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
- Z-0514-2022 — SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193058.
Data sourced from openFDA. This site is unofficial and independent of the FDA.