Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
FDA 510(k) clearance K221014 · decided 2022-10-17
Clearance details
- K-number
- K221014
- Device name
- Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
- Applicant
- Effortless Oxygen, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-04-05
- Decision date
- 2022-10-17
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- NFB
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Phoenix, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.