SKINTELL
System, Imaging, Optical Coherence Tomography (oct)
AGFA HEALTHCARE N.V.
The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Skintell.
Pre-market Notification Details
| Device ID | K132800 |
| 510k Number | K132800 |
| Device Name: | SKINTELL |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | AGFA HEALTHCARE N.V. 10 SOUTH ACADEMY STREET Greenville, SC 29601 |
| Contact | Shaeann Cavanagh |
| Correspondent | Shaeann Cavanagh AGFA HEALTHCARE N.V. 10 SOUTH ACADEMY STREET Greenville, SC 29601 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-06 |
| Decision Date | 2014-03-03 |
| Summary: | summary |
Trademark Results [SKINTELL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SKINTELL 85669625 5024746 Live/Registered |
AGFA NV 2012-07-05 |
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