VCTS 6500 System
FDA 510(k) K881023 · Vistech Consultants, Inc.
510(k) numberK881023
Submission
- Device name
- VCTS 6500 System
- Applicant
- Vistech Consultants, Inc.
Dayton, OH, US - Received
- March 10, 1988
- Decision date
- April 1, 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 |
| K882634 | Visual Contrast Sensiti., Potential Acuity&GlareHOX · Traditional | Vistech Consultants, Inc. | 07/15/1988SE |
| 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 |
| 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 |
|---|---|---|
| K882634 | Visual Contrast Sensiti., Potential Acuity&GlareHOX · Traditional | 07/15/1988SE |
| K881059 | MCT 8000 (Multi-Vision Contrast Tester)HOX · Traditional | 04/04/1988SE |
| 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 VCTS 6500 System cleared by the FDA?
VCTS 6500 System (K881023) received a 510(k) decision of Substantially Equivalent on April 1, 1988, 22 days after the submission was received.
What is the product code of K881023?
The FDA product code is HOX – Chart, Visual Acuity, a Class I (low risk) device regulated under 21 CFR 886.1150.