FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
INFRASCANNER, MODEL 1000
K Number: DEN100002
·
Decision Dec 13, 2011
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
5
Review Days
614
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INFRASCANNER, MODEL 1000
- K Number
- DEN100002
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 882.1935
- Medical Specialty
- Ophthalmic
- Decision
- Unknown
- Applicant
- Infrascan, Inc.
- Date Received
- April 8, 2010
- Decision Date
- December 13, 2011
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OPT), ordered by most recent decision date.
Infrascanner Model 2500 (Model 2500)
FDA 510(k)
FDA Class 2
·Ophthalmic
Infrascanner
FDA 510(k)
FDA Class 2
·Ophthalmic
Infrascanner
FDA 510(k)
FDA Class 2
·Ophthalmic
INFRASCANNER
FDA 510(k)
FDA Class 2
·Ophthalmic