CONTEC Oxygen Concentrator
FDA 510(k) clearance K180837 · decided 2019-01-10
Clearance details
- K-number
- K180837
- Device name
- CONTEC Oxygen Concentrator
- Applicant
- Contec Medical System Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-03-30
- Decision date
- 2019-01-10
- Days to decision
- 286 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Qinhuangdao, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.