Digilab Micro One Applanation Tonometer
FDA 510(k) K870121 · Bio-Rad
510(k) numberK870121
Submission
- Device name
- Digilab Micro One Applanation Tonometer
- Applicant
- Bio-Rad
Beverly, MA, US - Received
- January 12, 1987
- Decision date
- February 20, 1987
- 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 Micro One Applanation Tonometer cleared by the FDA?
Digilab Micro One Applanation Tonometer (K870121) received a 510(k) decision of Substantially Equivalent on February 20, 1987, 39 days after the submission was received.
What is the product code of K870121?
The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.