The following data is part of a premarket notification filed by Dymax Corp. with the FDA for Dymax Personal Scanner.
| Device ID | K862127 |
| 510k Number | K862127 |
| Device Name: | DYMAX PERSONAL SCANNER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | DYMAX CORP. 604 EPSILON DR. Pittsburgh, PA 15238 |
| Contact | Irene R Skolnick |
| Correspondent | Irene R Skolnick DYMAX CORP. 604 EPSILON DR. Pittsburgh, PA 15238 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-04 |
| Decision Date | 1986-12-11 |