The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Nova Microsonics Capricorn Digital Image Systems.
Device ID | K905248 |
510k Number | K905248 |
Device Name: | NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS |
Classification | Computer, Diagnostic, Programmable |
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 | DQK |
CFR Regulation Number | 870.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-21 |
Decision Date | 1991-02-28 |