NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
FDA 510(k) clearance K013694 · decided 2002-11-19
Clearance details
- K-number
- K013694
- Device name
- NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
- Applicant
- Nidek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-11-07
- Decision date
- 2002-11-19
- Days to decision
- 377 days
- Clearance type
- Traditional
- Product code
- NFJ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Lake Forest, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S016) | Nidek, Inc. | 1990-03-13 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S015) | Nidek, Inc. | 1989-09-08 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S014) | Nidek, Inc. | 1989-08-30 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S012) | Nidek, Inc. | 1988-07-28 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S011) | Nidek, Inc. | 1987-06-11 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S009) | Nidek, Inc. | 1987-04-08 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S010) | Nidek, Inc. | 1986-12-01 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S007) | Nidek, Inc. | 1985-11-26 |