Salter Labs Bubble Humidifier
FDA 510(k) clearance K161719 · decided 2017-09-21
Clearance details
- K-number
- K161719
- Device name
- Salter Labs Bubble Humidifier
- Applicant
- Salter Labs
- Decision
- Substantially Equivalent
- Date received
- 2016-06-22
- Decision date
- 2017-09-21
- Days to decision
- 456 days
- Clearance type
- Traditional
- Product code
- BTT
- Device class
- 2
- Regulation number
- 868.5450
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.