The following data is part of a premarket notification filed by Faxitron Bioptics Llc with the FDA for Biovision Plus.
| Device ID | K153583 |
| 510k Number | K153583 |
| Device Name: | BioVision Plus |
| Classification | Cabinet, X-ray System |
| Applicant | FAXITRON BIOPTICS LLC 3440 E. BRITANNIA DRIVE SUITE 150 Tucson, AZ 85743 |
| Contact | Carlos Reyes |
| Correspondent | Carlos Reyes FAXITRON BIOPTICS LLC 3440 E. BRITANNIA DRIVE SUITE 150 Tucson, AZ 85743 |
| Product Code | MWP |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-15 |
| Decision Date | 2016-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857069006210 | K153583 | 000 |
| 00857069006043 | K153583 | 000 |