EzRay Air W
510(k) K163705
EzRay Air W is a medical device (FDA Class II; FDA product code EHD, Unit, X-Ray, Extraoral With Timer) made by Vatech Co., Ltd., cleared under FDA 510(k) K163705 on 24 Jan 2017, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163705 | Date24 Jan 2017 | StatusActive |
Official records
- FDA 510(k) database K163705
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EHD
- Device class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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