Digilab Modular One-Applanation Tonometer
FDA 510(k) K863217 · Bio-Rad
510(k) numberK863217
Submission
- Device name
- Digilab Modular One-Applanation Tonometer
- Applicant
- Bio-Rad
Beverly, MA, US - Received
- August 20, 1986
- Decision date
- September 24, 1986
- 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 Digilab Modular One-Applanation Tonometer cleared by the FDA?
Digilab Modular One-Applanation Tonometer (K863217) received a 510(k) decision of Substantially Equivalent on September 24, 1986, 35 days after the submission was received.
What is the product code of K863217?
The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.