The following data is part of a premarket notification filed by Quantum Medical Systems, Inc. with the FDA for Qad Angiodynograph Ultrasound: Color Doppler Eval..
Device ID | K890998 |
510k Number | K890998 |
Device Name: | QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL. |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | QUANTUM MEDICAL SYSTEMS, INC. 1040 12TH AVE. Issaquah, WA 98027 |
Contact | Terrence J Sweeney |
Correspondent | Terrence J Sweeney QUANTUM MEDICAL SYSTEMS, INC. 1040 12TH AVE. Issaquah, WA 98027 |
Product Code | IYN |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-03 |
Decision Date | 1989-05-02 |