The following data is part of a premarket notification filed by Visionscope Technologies, Llc with the FDA for Visionscope High Definition Endoscopy Camera System With; Camera Control Unit; Camera Handpiece; Visionscope Endoscopes.
| Device ID | K101734 |
| 510k Number | K101734 |
| Device Name: | VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES |
| Classification | Arthroscope |
| Applicant | VISIONSCOPE TECHNOLOGIES, LLC 2352 MAIN STREET SUITE 303 Concord, MA 01742 |
| Contact | Lim Cheung Ph.d |
| Correspondent | Lim Cheung Ph.d VISIONSCOPE TECHNOLOGIES, LLC 2352 MAIN STREET SUITE 303 Concord, MA 01742 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-21 |
| Decision Date | 2010-09-08 |
| Summary: | summary |