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 |