Nidek Ar-1200
by Nidek, Inc.
510(k) K890559
Nidek Ar-1200 is a medical device (FDA Class I; FDA product code HKO, Refractometer, Ophthalmic) made by Nidek, Inc., cleared under FDA 510(k) K890559 on 27 Feb 1989, 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 | NumberK890559 | Date27 Feb 1989 | StatusActive |
Official records
- FDA 510(k) database K890559
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HKO
- Device class
- Class I
- Regulation
- 21 CFR Part 886.1760
- Advisory committee
- Ophthalmic
- FDA decision
- SESE Substantially Equivalent
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