FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Infrascanner
K Number: K200203
·
Decision Jul 10, 2020
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
5
Review Days
164
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Basic Information
- Device Name
- Infrascanner
- K Number
- K200203
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1935
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Infrascan, Inc.
- Date Received
- January 28, 2020
- Decision Date
- July 10, 2020
- Product Code
- OPT
- Advisory Committee
- Ophthalmic
- 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 |
|---|---|---|---|
| OPT | Infrared Hematoma Detector | FDA class 2 | Ophthalmic |
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