KOWA nonmyd 8
FDA 510(k) K191945 · Kowa Company , Ltd.
510(k) numberK191945
Submission
- Device name
- KOWA nonmyd 8
- Applicant
- Kowa Company , Ltd.
Chofu-Shi, JP - Received
- July 22, 2019
- Decision date
- September 10, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HKI – Camera, Ophthalmic, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1120
- Specialty
- Ophthalmic
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More from Optina Diagnostics, Inc.
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|---|---|---|
| K222372 | Kowa SL-19HJO · Traditional | 11/21/2022SE |
| K190573 | KOWA DR-1aHKI · Traditional | 06/04/2019SE |
| K133755 | Kowa SL-17HJO · Traditional | 03/11/2014SE |
| K112330 | Kowa VX-20HKI · Traditional | 02/16/2012SE |
| K101628 | Kowa Nonmyd WXHKI · Traditional | 01/26/2011SE |
| K091098 | Kowagenesis-DfHKI · Traditional | 08/07/2009SE |
| K091039 | Kowa, FM-600, Model LSS50MYC · Traditional | 08/07/2009SE |
| K091683 | Kowa VX-10 aHKI · Special | 07/02/2009SE |
| K083387 | Modification to Kowa Nonmyd Alpha-DiiiHKI · Special | 01/16/2009SE |
| K082767 | Kowa Nonmyd Alpha-DiiiHKI · Special | 10/21/2008SE |
Questions and answers
When was KOWA nonmyd 8 cleared by the FDA?
KOWA nonmyd 8 (K191945) received a 510(k) decision of Substantially Equivalent on September 10, 2019, 50 days after the submission was received.
What is the product code of K191945?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.