Salter Labs Bubble Humidifier— 510(k) K161719
Substantially EquivalentSalter Labs
FDA 510(k) clearance K161719 for Salter Labs Bubble Humidifier, Substantially Equivalent on 2017-09-21. Applicant: Salter Labs. Device class: 2.
Clearance details
- Applicant
- Salter Labs
- Product code
- Code BTT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5450
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code BTT
view allMore clearances from Salter Labs
view all- K261389 — PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)
- K151874 — BiNAPS Nasal Airflow and Snore Transducer +1 more
- K151506 — Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
- K151421 — Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines
- K143700 — CPAP Cannulaide
Adverse events under product code BTT
product code BTT- Death
- 60
- Injury
- 152
- Malfunction
- 7,232
- Other
- 2
- Total
- 7,446
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.