FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
GLOW800
K Number: K181537
·
Decision Sep 7, 2018
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
198
Applicant Total
4
Review Days
88
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Basic Information
- Device Name
- GLOW800
- K Number
- K181537
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1600
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Leica Microsystems (Schweiz) AG
- Date Received
- June 11, 2018
- Decision Date
- September 7, 2018
- Product Code
- IZI
- Advisory Committee
- Radiology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IZI | System, X-Ray, Angiographic | FDA class 2 | Radiology |
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