510(k) DEN100002
- Device
- INFRASCANNER, MODEL 1000
- Applicant
- Infrascan, Inc.
- 510(k) number
- DEN100002
- Product code
- OPT
- Decision
- Unknown (DENG)
- Decision date
- 2011-12-13
- Date received
- 2010-04-08
- Regulation
- 882.1935
- Classification name
- Infrared Hematoma Detector
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- STEVEN B DATLOF
- Address
- 3508 Market St., Suite 215 Philadelphia PA US 19104 19104
FDA Registration Numbers#
- 3006059345
- 3007204745
Source Documents#
510(k) summary PDF not indicated by FDA