Huvitz Imaging System
FDA 510(k) K191615 · Huvitz Co., Ltd.
510(k) numberK191615
Submission
- Device name
- Huvitz Imaging System
- Applicant
- Huvitz Co., Ltd.
Anyang-Si, Dongan-Gu, KR - Received
- June 18, 2019
- Decision date
- July 18, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Huvitz Imaging System cleared by the FDA?
Huvitz Imaging System (K191615) received a 510(k) decision of Substantially Equivalent on July 18, 2019, 30 days after the submission was received.
What is the product code of K191615?
The FDA product code is NFJ – System, Image Management, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 892.2050.