Visual Contrast Sensiti., Potential Acuity&Glare
FDA 510(k) K882634 · Vistech Consultants, Inc.
510(k) numberK882634
Submission
- Device name
- Visual Contrast Sensiti., Potential Acuity&Glare
- Applicant
- Vistech Consultants, Inc.
Dayton, OH, US - Received
- June 27, 1988
- Decision date
- July 15, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HOX – Chart, Visual Acuity
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1150
- Specialty
- Ophthalmic
Other 510(k)s with product code HOX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100095 | Central Vision Analyzer Model 1000HOX · Abbreviated | Vimetrics,Llc. | 05/10/2010SE |
| K944156 | Heine Lambda 100HOX · Traditional | Heine USA , Ltd. | 01/12/1995SE |
| K881971 | Occu-Tech Vision TestHOX · Traditional | Applied Vision Concepts, Inc. | 11/25/1988SE |
| K883337 | PL 20/20 Infant Vision TesterHOX · Traditional | Optimed Technologies, Inc. | 10/31/1988SE |
| K881358 | PG Consen Contrast Sensitivity Testing ProgramHOX · Traditional | Neuroscientific Corp. | 06/27/1988SE |
| K881059 | MCT 8000 (Multi-Vision Contrast Tester)HOX · Traditional | Vistech Consultants, Inc. | 04/04/1988SE |
| K881023 | VCTS 6500 SystemHOX · Traditional | Vistech Consultants, Inc. | 04/01/1988SE |
| K881022 | VCTS Marketing Program SystemHOX · Traditional | Vistech Consultants, Inc. | 04/01/1988SE |
| K881021 | VCTS 700S SystemHOX · Traditional | Vistech Consultants, Inc. | 04/01/1988SE |
| K880647 | Adult Perceptual Motor Puzzles (5331-01)HOX · Traditional | Fred Sammons, Inc. | 04/01/1988SE |
More from Fred Sammons, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K881059 | MCT 8000 (Multi-Vision Contrast Tester)HOX · Traditional | 04/04/1988SE |
| K881023 | VCTS 6500 SystemHOX · Traditional | 04/01/1988SE |
| K881022 | VCTS Marketing Program SystemHOX · Traditional | 04/01/1988SE |
| K881021 | VCTS 700S SystemHOX · Traditional | 04/01/1988SE |
| K853481 | Vistech VCTS Glare TesterHOX · Traditional | 10/29/1985SE |
| K840255 | Vistech VCTS 6000HOX · Traditional | 04/13/1984SE |
Questions and answers
When was Visual Contrast Sensiti., Potential Acuity&Glare cleared by the FDA?
Visual Contrast Sensiti., Potential Acuity&Glare (K882634) received a 510(k) decision of Substantially Equivalent on July 15, 1988, 18 days after the submission was received.
What is the product code of K882634?
The FDA product code is HOX – Chart, Visual Acuity, a Class I (low risk) device regulated under 21 CFR 886.1150.