The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Level 10 Hdi.
| Device ID | K961459 |
| 510k Number | K961459 |
| Device Name: | LEVEL 10 HDI |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | Terrance J Sweeney |
| Correspondent | Terrance J Sweeney ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-16 |
| Decision Date | 1997-03-26 |
| Summary: | summary |