Coopervision System Vi
FDA 510(k) K842945 · CooperVision, Inc.
510(k) numberK842945
Submission
- Device name
- Coopervision System Vi
- Applicant
- CooperVision, Inc.
Irvine, CA, US - Received
- July 25, 1984
- Decision date
- December 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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Questions and answers
When was Coopervision System Vi cleared by the FDA?
Coopervision System Vi (K842945) received a 510(k) decision of Substantially Equivalent on December 11, 1984, 139 days after the submission was received.
What is the product code of K842945?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.