Thermoplastic Masks
by Aktina Medical Corp United States 510(k)
510(k) K192102
Product code IYE
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192102 | Date25 Sep 2019 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYE
- FDA applicant
- Aktina Medical Corporation
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Aktina Medical Corp
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K192102