AR-1600G AUTO-REFRACTOMETER
FDA 510(k) clearance K902500 · decided 1990-07-27
Clearance details
- K-number
- K902500
- Device name
- AR-1600G AUTO-REFRACTOMETER
- Applicant
- Nidek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-06-05
- Decision date
- 1990-07-27
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- HKO
- Device class
- 1
- Regulation number
- 886.1760
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Palo Alto, CA, US
- 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 |
|---|---|---|
| TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM (K031831) | Topcon Medical Systems, Inc. | 2003-12-19 |
| WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 (K000327) | Visx, Incorporated | 2000-05-02 |
| DIGITAL RETINOSCOPIC PHOTOMETER (K951179) | Kudi Kalu, Inc. | 1995-05-30 |
| VIDEO VISION ANALYZER (VIVA), VRB 100 (K945959) | Tomey Corporation USA | 1995-03-01 |
| AUTO REF-KERATOMETER, RK-3 (K942242) | Cannon U.S.A., Inc. | 1994-09-02 |
| AUTO REFF-30 (K940516) | Canon, Inc. | 1994-07-12 |
| AUTOREF LENSMETER RL-10 (K925304) | Canon USA, Inc. | 1994-02-17 |
| OPTEC 3000 (K924741) | Stereo Optical Co., Inc. | 1993-04-06 |
| BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 (K924778) | R.H. Burton Co. | 1993-04-05 |
| BURTON AUTO REFRACTOR - MODEL BAR-7 (K924790) | R.H. Burton Co. | 1993-04-05 |
| OPTEC 2300 AFVT, ARMED FORCES VISION TESTER (K904828) | Stereo Optical Co., Inc. | 1991-01-18 |
| SHIN NIPPON AUTO REFRACTOMETER QR-007N (K901583) | Soderberg, Inc. | 1990-06-22 |
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 |