The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for M2424a Sonos 5500/4500 Diagnostic Ultrasound System, Version B.2. 21330a Transducer.
| Device ID | K002470 |
| 510k Number | K002470 |
| Device Name: | M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Ann F Michaels |
| Correspondent | Carole Stamp TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-08-11 |
| Decision Date | 2000-09-08 |