The following data is part of a premarket notification filed by Diagnostic Medical Systems with the FDA for Explorer Cvs Transcranial Doppler.
| Device ID | K990517 |
| 510k Number | K990517 |
| Device Name: | EXPLORER CVS TRANSCRANIAL DOPPLER |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | DIAGNOSTIC MEDICAL SYSTEMS PO BOX 12038 La Jolla, CA 92039 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson DIAGNOSTIC MEDICAL SYSTEMS PO BOX 12038 La Jolla, CA 92039 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-18 |
| Decision Date | 2000-08-01 |
| Summary: | summary |