Micron-Scope II
FDA 510(k) K926412 · Chiron Vision Corp.
510(k) numberK926412
Submission
- Device name
- Micron-Scope II
- Applicant
- Chiron Vision Corp.
Irvine, CA, US - Received
- December 21, 1992
- Decision date
- July 19, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HMS – Drum, Eye Knife Test
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4230
- Specialty
- Ophthalmic
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Questions and answers
When was Micron-Scope II cleared by the FDA?
Micron-Scope II (K926412) received a 510(k) decision of Substantially Equivalent on July 19, 1994, 575 days after the submission was received.
What is the product code of K926412?
The FDA product code is HMS – Drum, Eye Knife Test, a Class I (low risk) device regulated under 21 CFR 886.4230.