The following data is part of a premarket notification filed by Accutome, Inc. with the FDA for Accusonic A-scan Model, 24-4000.
| Device ID | K032956 |
| 510k Number | K032956 |
| Device Name: | ACCUSONIC A-SCAN MODEL, 24-4000 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ACCUTOME, INC. 263 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Contact | Jeffrey L Wright |
| Correspondent | Jeffrey L Wright ACCUTOME, INC. 263 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-22 |
| Decision Date | 2003-10-10 |
| Summary: | summary |