The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Acoustically-coupled Electronic Phantom 84-410.
| Device ID | K853755 |
| 510k Number | K853755 |
| Device Name: | ACOUSTICALLY-COUPLED ELECTRONIC PHANTOM 84-410 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | VICTOREEN, INC. 100 VOICE RD. Carle Place, NY 11514 |
| Contact | Glasser |
| Correspondent | Glasser VICTOREEN, INC. 100 VOICE RD. Carle Place, NY 11514 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-09 |
| Decision Date | 1985-11-26 |