The following data is part of a premarket notification filed by Visionsense Ltd with the FDA for Vs3 Stereoscopic High Definition Vision System.
| Device ID | K153548 |
| 510k Number | K153548 |
| Device Name: | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM |
| Classification | Arthroscope |
| Applicant | VISIONSENSE LTD 20 HAMAGSHIMIM ST Petach Tikva, Hamerkaz, IL 49348 |
| Contact | Alex Chanin |
| Correspondent | Raymond Kelly LICENSALE INC 57 LAZY BROOK RD Monroe, CT 06468 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-11 |
| Decision Date | 2016-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18130400103403 | K153548 | 000 |