The following data is part of a premarket notification filed by Intravista Medical Systems Inc with the FDA for Led Lamp Or Other.
| Device ID | K092883 |
| 510k Number | K092883 |
| Device Name: | LED LAMP OR OTHER |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | INTRAVISTA MEDICAL SYSTEMS INC 1567 SAMEDRA ST Sunnyvale, CA 94087 |
| Contact | Wei Su |
| Correspondent | Wei Su INTRAVISTA MEDICAL SYSTEMS INC 1567 SAMEDRA ST Sunnyvale, CA 94087 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-18 |
| Decision Date | 2009-12-18 |