Burton Applanation Tonometer - Model T850 & T1000
FDA 510(k) K924777 · R.H. Burton Co.
510(k) numberK924777
Submission
- Device name
- Burton Applanation Tonometer - Model T850 & T1000
- Applicant
- R.H. Burton Co.
Grove City, OH, US - Received
- September 23, 1992
- Decision date
- April 5, 1993
- 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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More from Canon Inc. -Medical Equipment Group
| 510(k) | Device | Decision |
|---|---|---|
| K924773 | Burton H- Base Table - Model 1990HRX · Traditional | 06/07/1993SE |
| K924786 | Burton Trial Lens SetHPC · Traditional | 04/14/1993SE |
| K924783 | Burton Slit Lamp - Model 850HJO · Traditional | 04/14/1993SE |
| K924774 | Burton Automatic Projector - Model CP-40HOD · Traditional | 04/14/1993SE |
| K924790 | Burton Auto Refractor - Model BAR-7HKO · Traditional | 04/05/1993SE |
| K924788 | Burton LensmeterHLM · Traditional | 04/05/1993SE |
| K924785 | Burton Radiusgauge - Model 2030HLM · Traditional | 04/05/1993SE |
| K924784 | Burton Projector Head - Model 6000-HHOS · Traditional | 04/05/1993SE |
| K924780 | Burton Ophthalmic Exam Unit - Model 2201HMF · Traditional | 04/05/1993SE |
| K924779 | Burton Keratometer - Modle 2040HJB · Traditional | 04/05/1993SE |
Questions and answers
When was Burton Applanation Tonometer - Model T850 & T1000 cleared by the FDA?
Burton Applanation Tonometer - Model T850 & T1000 (K924777) received a 510(k) decision of Substantially Equivalent on April 5, 1993, 194 days after the submission was received.
What is the product code of K924777?
The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.