The following data is part of a premarket notification filed by Accutome Ultrasound, Inc. with the FDA for Accupach V.
| Device ID | K042752 |
| 510k Number | K042752 |
| Device Name: | ACCUPACH V |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ACCUTOME ULTRASOUND, INC. 263 GREAT VALLEY PARKWAY Malvern, PA 19355 |
| Contact | Jeffrey L Wright |
| Correspondent | Jeffrey L Wright ACCUTOME ULTRASOUND, INC. 263 GREAT VALLEY PARKWAY 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 | 2004-10-04 |
| Decision Date | 2004-11-10 |
| Summary: | summary |