The following data is part of a premarket notification filed by Biovision Technologies, Llc with the FDA for Needlecam Hd Visualization System.
| Device ID | K143705 |
| 510k Number | K143705 |
| Device Name: | NeedleCam HD Visualization System |
| Classification | Arthroscope |
| Applicant | BIOVISION TECHNOLOGIES, LLC 221 CORPORATE CIRCLE UNIT H Golden, CO 80401 |
| Contact | David Sanso |
| Correspondent | David Sanso BIOVISION TECHNOLOGIES, LLC 221 CORPORATE CIRCLE UNIT H Golden, CO 80401 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-29 |
| Decision Date | 2015-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851582006108 | K143705 | 000 |
| 00851582006047 | K143705 | 000 |