The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Color Flow Imaging.
Device ID | K873096 |
510k Number | K873096 |
Device Name: | COLOR FLOW IMAGING |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
Contact | John Dellinger |
Correspondent | John Dellinger 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 | 1987-08-07 |
Decision Date | 1987-11-23 |