2300 SERIES MGO PORTABLE OXYGEN
FDA 510(k) clearance K134023 · decided 2014-04-25
Clearance details
- K-number
- K134023
- Device name
- 2300 SERIES MGO PORTABLE OXYGEN
- Applicant
- Ultra Electronics Limited Precision Air & Land SY
- Decision
- Substantially Equivalent
- Date received
- 2013-12-30
- Decision date
- 2014-04-25
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Cheltenham, Gloucestershire, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.