GLOW800
FDA 510(k) K181537 · Leica Microsystems (Schweiz) AG
510(k) numberK181537
Submission
- Device name
- GLOW800
- Applicant
- Leica Microsystems (Schweiz) AG
Heerbrugg, CH - Received
- June 11, 2018
- Decision date
- September 7, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was GLOW800 cleared by the FDA?
GLOW800 (K181537) received a 510(k) decision of Substantially Equivalent on September 7, 2018, 88 days after the submission was received.
What is the product code of K181537?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.