The following data is part of a premarket notification filed by Biovision Technologies, Llc with the FDA for Needle View Ch Scope Kits.
| Device ID | K141326 |
| 510k Number | K141326 |
| Device Name: | NEEDLE VIEW CH SCOPE KITS |
| Classification | Arthroscope |
| Applicant | BIOVISION TECHNOLOGIES, LLC 221 CORPORATE CIRCLE SUITE H Golden, CO 80401 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-21 |
| Decision Date | 2014-10-08 |
| Summary: | summary |