The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Nova Microsonics Access Image Management Network/access Acquisition Module.
| Device ID | K940423 |
| 510k Number | K940423 |
| Device Name: | NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE |
| Classification | System, Digital Image Communications, Radiological |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | Terrence J Sweeney |
| Correspondent | Terrence J Sweeney ADVANCED TECHNOLOGY LABORATORIES, INC. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Product Code | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-31 |
| Decision Date | 1994-07-29 |