PL 20/20 INFANT VISION TESTER
FDA 510(k) clearance K883337 · decided 1988-10-31
Clearance details
- K-number
- K883337
- Device name
- PL 20/20 INFANT VISION TESTER
- Applicant
- Optimed Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-08-09
- Decision date
- 1988-10-31
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- HOX
- Device class
- 1
- Regulation number
- 886.1150
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Lawrence, KS, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Optimed Technologies
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CENTRAL VISION ANALYZER MODEL 1000 (K100095) | Vimetrics,Llc. | 2010-05-10 |
| HEINE LAMBDA 100 (K944156) | Heine USA , Ltd. | 1995-01-12 |
| OCCU-TECH VISION TEST (K881971) | Applied Vision Concepts, Inc. | 1988-11-25 |
| VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE (K882634) | Vistech Consultants, Inc. | 1988-07-15 |
| PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM (K881358) | Neuroscientific Corp. | 1988-06-27 |
| MCT 8000 (MULTI-VISION CONTRAST TESTER) (K881059) | Vistech Consultants, Inc. | 1988-04-04 |
| VCTS 700S SYSTEM (K881021) | Vistech Consultants, Inc. | 1988-04-01 |
| VCTS 6500 SYSTEM (K881023) | Vistech Consultants, Inc. | 1988-04-01 |
| VCTS MARKETING PROGRAM SYSTEM (K881022) | Vistech Consultants, Inc. | 1988-04-01 |
| ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) (K880647) | Fred Sammons, Inc. | 1988-04-01 |
| OPTEC 1000 DMV VISION TESTER MODIFY (K875237) | Stereo Optical Co., Inc. | 1988-03-17 |
| MENTOR B-VAT(TM) II VIDEO TESTER (K875112) | Mentor O & O, Inc. | 1988-03-08 |
Recalls involving this device
No recalls on record reference this clearance.