FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIR 800
K Number: K202391
·
Decision Jan 21, 2021
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
198
Applicant Total
207
Review Days
153
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Basic Information
- Device Name
- DIR 800
- K Number
- K202391
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1600
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aesculap, Inc.
- Date Received
- August 21, 2020
- Decision Date
- January 21, 2021
- 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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