Optional Probe of Canon Iol Estimator KU-1
FDA 510(k) K891225 · Canon USA, Inc.
510(k) numberK891225
Submission
- Device name
- Optional Probe of Canon Iol Estimator KU-1
- Applicant
- Canon USA, Inc.
Jericho, NY, US - Received
- March 7, 1989
- Decision date
- May 31, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Optional Probe of Canon Iol Estimator KU-1 cleared by the FDA?
Optional Probe of Canon Iol Estimator KU-1 (K891225) received a 510(k) decision of Substantially Equivalent on May 31, 1989, 85 days after the submission was received.
What is the product code of K891225?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.