The following data is part of a premarket notification filed by Rightmedical Products, Llc with the FDA for Rs-1000 Zoom Slitlamp With Option.
| Device ID | K060869 |
| 510k Number | K060869 |
| Device Name: | RS-1000 ZOOM SLITLAMP WITH OPTION |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | RIGHTMEDICAL PRODUCTS, LLC 200 EXPRESSWAY COURT Virginia Beach, VA 23462 |
| Contact | Harumi Kumahara |
| Correspondent | Harumi Kumahara RIGHTMEDICAL PRODUCTS, LLC 200 EXPRESSWAY COURT Virginia Beach, VA 23462 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-30 |
| Decision Date | 2006-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04562230691848 | K060869 | 000 |
| 04562230691817 | K060869 | 000 |
| 04562230691756 | K060869 | 000 |
| 04562230691640 | K060869 | 000 |