The following data is part of a premarket notification filed by Rodenstock Instrument Corp. with the FDA for Rodenstock Scanning Laser Ophthalmoscope.
| Device ID | K882517 |
| 510k Number | K882517 |
| Device Name: | RODENSTOCK SCANNING LASER OPHTHALMOSCOPE |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | RODENSTOCK INSTRUMENT CORP. 20 STANIFORD ST. Boston, MA 02114 |
| Contact | Ulrich Klingbeil,phd |
| Correspondent | Ulrich Klingbeil,phd RODENSTOCK INSTRUMENT CORP. 20 STANIFORD ST. Boston, MA 02114 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-17 |
| Decision Date | 1989-01-24 |