O2asis Personal Oxygen Humidifier
FDA 510(k) clearance K193411 · decided 2020-11-12
Clearance details
- K-number
- K193411
- Device name
- O2asis Personal Oxygen Humidifier
- Applicant
- Perma Pure, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-12-09
- Decision date
- 2020-11-12
- Days to decision
- 339 days
- Clearance type
- Traditional
- Product code
- BTT
- Device class
- 2
- Regulation number
- 868.5450
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Lakewood, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.