The following data is part of a premarket notification filed by Quantum Medical Systems, Inc. with the FDA for Quantum Qad Angiodynograph Ultrasound System.
| Device ID | K894992 |
| 510k Number | K894992 |
| Device Name: | QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM |
| Classification | Monitor, Fetal Doppler Ultrasound |
| 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 | MAA |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-08 |
| Decision Date | 1990-02-23 |