Baylow Visual Acuity Tester
FDA 510(k) K781452 · Codman & Shurtleff, Inc.
510(k) numberK781452
Submission
- Device name
- Baylow Visual Acuity Tester
- Applicant
- Codman & Shurtleff, Inc.
Mchenry, IL, US - Received
- August 23, 1978
- Decision date
- October 24, 1978
- 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
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|---|---|---|---|
| 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 |
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Questions and answers
When was Baylow Visual Acuity Tester cleared by the FDA?
Baylow Visual Acuity Tester (K781452) received a 510(k) decision of Substantially Equivalent on October 24, 1978, 62 days after the submission was received.
What is the product code of K781452?
The FDA product code is HOX – Chart, Visual Acuity, a Class I (low risk) device regulated under 21 CFR 886.1150.