The following data is part of a premarket notification filed by Bionix Development Corp. with the FDA for Versaboard, Model 7040.
| Device ID | K030051 |
| 510k Number | K030051 |
| Device Name: | VERSABOARD, MODEL 7040 |
| Classification | Accelerator, Linear, Medical |
| Applicant | BIONIX DEVELOPMENT CORP. 5154 ENTERPRISE BLVD. Toledo, OH 43612 |
| Contact | James Huttner |
| Correspondent | James Huttner BIONIX DEVELOPMENT CORP. 5154 ENTERPRISE BLVD. Toledo, OH 43612 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-06 |
| Decision Date | 2003-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817740020515 | K030051 | 000 |
| 00817740020508 | K030051 | 000 |
| 00817740020478 | K030051 | 000 |
| 00817740020126 | K030051 | 000 |
| 00817740020102 | K030051 | 000 |