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 |