Ao Non-Contact II Tonometer
FDA 510(k) K802419 · American Optical Corp.
510(k) numberK802419
Submission
- Device name
- Ao Non-Contact II Tonometer
- Applicant
- American Optical Corp.
Mchenry, IL, US - Received
- October 6, 1980
- Decision date
- November 12, 1980
- 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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Questions and answers
When was Ao Non-Contact II Tonometer cleared by the FDA?
Ao Non-Contact II Tonometer (K802419) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 37 days after the submission was received.
What is the product code of K802419?
The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.