The following data is part of a premarket notification filed by Sonomed, Inc. with the FDA for E-z Scan Ab5500+.
| Device ID | K040668 |
| 510k Number | K040668 |
| Device Name: | E-Z SCAN AB5500+ |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SONOMED, INC. 377 ROUTE 17 S Hansbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers SONOMED, INC. 377 ROUTE 17 S Hansbrouck Heights, NJ 07604 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-15 |
| Decision Date | 2004-04-13 |
| Summary: | summary |