EPI K Console
by Moria SA
510(k) K172994
EPI K Console is a medical device (FDA Class I; FDA product code HNO, Keratome, Ac-Powered) made by Moria SA, cleared under FDA 510(k) K172994 on 26 Oct 2017, active as of 11 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 | NumberK172994 | Date26 Oct 2017 | StatusActive |
Official records
- FDA 510(k) database K172994
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HNO
- Device class
- Class I
- Regulation
- 21 CFR Part 886.4370
- Advisory committee
- Ophthalmic
- FDA decision
- SESE Substantially Equivalent
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