Ergo Diagnostic Card
FDA 510(k) K834145 · American Ergo Systems
510(k) numberK834145
Submission
- Device name
- Ergo Diagnostic Card
- Applicant
- American Ergo Systems
Mchenry, IL, US - Received
- December 1, 1983
- Decision date
- March 16, 1984
- 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 |
| 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 |
Questions and answers
When was Ergo Diagnostic Card cleared by the FDA?
Ergo Diagnostic Card (K834145) received a 510(k) decision of Substantially Equivalent on March 16, 1984, 106 days after the submission was received.
What is the product code of K834145?
The FDA product code is HOX – Chart, Visual Acuity, a Class I (low risk) device regulated under 21 CFR 886.1150.