SACCADOMETER PLUS, SACCADOMETER ADVANCED
FDA 510(k) clearance K152890 · decided 2016-08-11
Clearance details
- K-number
- K152890
- Device name
- SACCADOMETER PLUS, SACCADOMETER ADVANCED
- Applicant
- Ober Consulting Sp. Z.O.O.
- Decision
- Substantially Equivalent
- Date received
- 2015-09-30
- Decision date
- 2016-08-11
- Days to decision
- 316 days
- Clearance type
- Traditional
- Product code
- HLL
- Device class
- 2
- Regulation number
- 886.1510
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Poznan, PL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Retitrack (K222484) | C. Light Technologies, Inc. | 2023-05-09 |
| VARILUX VISIONPRINT SYSTEM (VPS) (K033949) | Essilor Intl. | 2004-07-02 |
| ORTHOTONE (K872111) | Orthotone Corp. | 1988-11-16 |
Recalls involving this device
No recalls on record reference this clearance.