Tonometer Tapes
FDA 510(k) K873917 · Richmond Products, Inc.
510(k) numberK873917
Submission
- Device name
- Tonometer Tapes
- Applicant
- Richmond Products, Inc.
Boca Raton, FL, US - Received
- September 25, 1987
- Decision date
- November 2, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HKX – Tonometer, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1930
- Specialty
- Ophthalmic
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| K223739 | VS Tabletop TonometerHKX · Traditional | Medimaging Integrated Solution, Inc. | 11/08/2023SE |
| K190382 | Intraocular Pressure Tonometer EASYTONHKX · Traditional | Company Elamed | 12/06/2019SE |
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| K180820 | Tono Vue Non-Contact TonometerHKX · Traditional | Crystalvue Medical Corporation | 12/14/2018SE |
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| K113066 | Corvis STHKX · Traditional | Oculus Optikgerate GmbH | 11/08/2012SE |
| K111710 | Full Auto Tonometer Model TX-20HKX · Special | Canon Inc. -Medical Equipment Group | 09/20/2011SE |
More from Canon Inc. -Medical Equipment Group
| 510(k) | Device | Decision |
|---|---|---|
| K874252 | Kreda DiscHOQ · Traditional | 01/27/1988SE |
| K874251 | Worth 4 Dot Test Distance C/W Muscle LightHLP · Traditional | 01/11/1988SE |
| K874250 | Three Char. Test-Child & Worth 4 Dot Test Nearpt.HLP · Traditional | 01/11/1988SE |
| K873907 | Confirmation TestsHPC · Traditional | 12/29/1987SE |
| K873908 | H.R.R. Pseudoisochromatic Color Blindness Test Bk.HIT · Traditional | 12/23/1987SE |
| K873916 | 'E' Cube and 'E' PadHOX · Traditional | 12/11/1987SE |
| K873914 | Animated Fixation Toys (Distance and Nearpoint)HPL · Traditional | 12/11/1987SE |
| K873913 | Color Book Illuminator StandHJD · Traditional | 12/02/1987SE |
| K873911 | Pseudo Isochromatic Color Blindness Test Book - 15HIT · Traditional | 12/02/1987SE |
| K873912 | Richmond Visual Field ScreenerHOO · Traditional | 11/02/1987SE |
Questions and answers
When was Tonometer Tapes cleared by the FDA?
Tonometer Tapes (K873917) received a 510(k) decision of Substantially Equivalent on November 2, 1987, 38 days after the submission was received.
What is the product code of K873917?
The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.