Non-Contact Tonometers, Ocular Response Analyzer
FDA 510(k) K032799 · Reichert, Inc.
510(k) numberK032799
Submission
- Device name
- Non-Contact Tonometers, Ocular Response Analyzer
- Applicant
- Reichert, Inc.
Depew, NY, US - Received
- September 9, 2003
- Decision date
- January 20, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K071839 | Soct Copernicus, Model 15205OBO · Traditional | 02/27/2008SE |
| K070534 | Modification to: Ocu-Film Tip CoverHKY · Special | 03/27/2007SE |
| K063750 | Xcel 255 Slit LampHJO · Traditional | 12/20/2006SE |
| K061330 | PSL Portable Slit LampHJO · Abbreviated | 05/25/2006SE |
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Questions and answers
When was Non-Contact Tonometers, Ocular Response Analyzer cleared by the FDA?
Non-Contact Tonometers, Ocular Response Analyzer (K032799) received a 510(k) decision of Substantially Equivalent on January 20, 2004, 133 days after the submission was received.
What is the product code of K032799?
The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.