FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Salter Labs Bubble Humidifier
K Number: K161719
·
Decision Sep 21, 2017
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
220
Applicant Total
48
Review Days
456
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Basic Information
- Device Name
- Salter Labs Bubble Humidifier
- K Number
- K161719
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5450
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Salter Labs
- Date Received
- June 22, 2016
- Decision Date
- September 21, 2017
- Product Code
- BTT
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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Other Clearances by Salter Labs
| K Number | Device Name | ||
|---|---|---|---|
| K151874 | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal | Apr 15, 2016 | Substantially Equivalent |
| K151506 | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula | Mar 11, 2016 | Substantially Equivalent |
| K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines | Mar 10, 2016 | Substantially Equivalent |
| K143700 | CPAP Cannulaide | Aug 5, 2015 | Substantially Equivalent |
| K142416 | Luma Wrap | Jun 12, 2015 | Substantially Equivalent |
| K092685 | PNEUMOTHERML, MODEL: 5800 | Nov 24, 2009 | Substantially Equivalent |
| K051313 | BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER | Sep 15, 2005 | Substantially Equivalent |
| K040202 | SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM | Mar 4, 2005 | Substantially Equivalent |
| K014056 | SALTER LABS MODIFIED NEBUTECH NEBULIZER | Feb 1, 2002 | Substantially Equivalent |
| K992285 | SALTER AIRE COMPRESSOR | Jan 7, 2000 | Substantially Equivalent |