Tomey Proton Tonometer
FDA 510(k) K924760 · Tomey Corporation USA
510(k) numberK924760
Submission
- Device name
- Tomey Proton Tonometer
- Applicant
- Tomey Corporation USA
Cambridge, MA, 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
- HKY – Tonometer, Manual
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1930
- Specialty
- Ophthalmic
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Questions and answers
When was Tomey Proton Tonometer cleared by the FDA?
Tomey Proton Tonometer (K924760) 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 K924760?
The FDA product code is HKY – Tonometer, Manual, a Class II (moderate risk) device regulated under 21 CFR 886.1930.