O2 Concepts Oxlife Independence Model 301-0001
FDA 510(k) clearance K182454 · decided 2018-12-20
Clearance details
- K-number
- K182454
- Device name
- O2 Concepts Oxlife Independence Model 301-0001
- Applicant
- O2 Concepts, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-09-07
- Decision date
- 2018-12-20
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Middlebury, CT, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.