MATRx plus
FDA 510(k) clearance DEN170090 · decided 2018-08-23
Clearance details
- K-number
- DEN170090
- Device name
- MATRx plus
- Applicant
- Zephyr Sleep Technologies
- Decision
- Unknown
- Date received
- 2017-12-21
- Decision date
- 2018-08-23
- Days to decision
- 245 days
- Clearance type
- Direct
- Product code
- QCJ
- Device class
- 2
- Regulation number
- 872.5571
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Calgary, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.