The following data is part of a premarket notification filed by Cortex Technology Aps with the FDA for Cortex Dermascan C Ultrasonic System.
| Device ID | K983945 |
| 510k Number | K983945 |
| Device Name: | CORTEX DERMASCAN C ULTRASONIC SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | CORTEX TECHNOLOGY APS SMEDEVAENGET 10 Hadsund, DK 9560 |
| Contact | George Myers |
| Correspondent | George Myers CORTEX TECHNOLOGY APS SMEDEVAENGET 10 Hadsund, DK 9560 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-05 |
| Decision Date | 1999-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05710188039000 | K983945 | 000 |
| 05710188035330 | K983945 | 000 |
| 05710188035316 | K983945 | 000 |
| 05710188035309 | K983945 | 000 |
| 05710188035293 | K983945 | 000 |