Nil
FDA 510(k) K943613 · Sing Wah International Enterprises , Ltd.
510(k) numberK943613
Submission
- Device name
- Nil
- Applicant
- Sing Wah International Enterprises , Ltd.
Connaught, HK - Received
- July 27, 1994
- Decision date
- September 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HOI – Spectacle, Magnifying
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.5840
- Specialty
- Ophthalmic
Other 510(k)s with product code HOI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K930435 | Spectacle FramesHOI · Traditional | Venis DI A. Vendrame | 09/20/1993SE |
| K931328 | Pyramid Sunglasses/Pyramid Reading GlassesHOI · Traditional | Pyramid | 08/10/1993SE |
| K910329 | SunglassesHOI · Traditional | Cutler & Gross Sloan Optical , Ltd. | 03/12/1991SE |
| K854854 | Systems of Sight Low Vision EyewareHOI · Traditional | Int'L Eye Care, Inc. | 02/04/1986SE |
| K844716 | Magnifying Spectacles W/Plastic LensesHOI · Traditional | Gazelle Corp. | 01/03/1985SE |
| K844038 | Visitec Magnifying SpectaclesHOI · Traditional | Visitec Co. | 11/29/1984SE |
| K842835 | Brillette ModelHOI · Traditional | Cillus Company, Inc. | 11/21/1984SE |
| K820732 | La Vel Lateral View Extension LensHOI · Traditional | Peter M. Tolliver | 05/03/1982SE |
| K813548 | Uvex Mini-SpecsHOI · Traditional | Bacou USA, Inc. and Uvex Safety, Inc. | 03/02/1982SE |
| K801733 | Fenzl ReticleHOI · Traditional | Robert E. Fenzl, M.D. | 09/16/1980SE |
More from Robert E. Fenzl, M.D.
| 510(k) | Device | Decision |
|---|---|---|
| K943263 | NilHQY · Traditional | 08/15/1994SE |
Questions and answers
When was Nil cleared by the FDA?
Nil (K943613) received a 510(k) decision of Substantially Equivalent on September 21, 1994, 56 days after the submission was received.
What is the product code of K943613?
The FDA product code is HOI – Spectacle, Magnifying, a Class I (low risk) device regulated under 21 CFR 886.5840.