The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for M2410b Imagepoint Hx Multispecialty System, Version B.1.
Device ID | K001711 |
510k Number | K001711 |
Device Name: | M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1 |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
Contact | Steve Singlar |
Product Code | IYN |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2000-06-05 |
Decision Date | 2000-06-20 |