The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Hdi 5000 Diagnostic Ultrasound System.
| Device ID | K991671 |
| 510k Number | K991671 |
| Device Name: | HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | Terrence J Sweeney |
| Correspondent | Terrence J Sweeney ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-17 |
| Decision Date | 1999-06-18 |
| Summary: | summary |