FDA 510(k)
FDA class 2
Unknown
🇨🇦 Canada
MATRx plus
K Number: DEN170090
·
Decision Aug 23, 2018
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
5
Review Days
245
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MATRx plus
- K Number
- DEN170090
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 872.5571
- Medical Specialty
- Dental
- Decision
- Unknown
- Applicant
- Zephyr Sleep Technologies
- Date Received
- December 21, 2017
- Decision Date
- August 23, 2018
- Product Code
- QCJ
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QCJ | Closed Loop Auto Titration Device For Oral Appliances | FDA class 2 | Dental |