The following data is part of a premarket notification filed by Drager Medizintechnik Gmbh with the FDA for Drager Sola Series, Models 1000/700/500/300.
| Device ID | K984611 |
| 510k Number | K984611 |
| Device Name: | DRAGER SOLA SERIES, MODELS 1000/700/500/300 |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | DRAGER MEDIZINTECHNIK GMBH 53/55 MOISLINGER ALLEE Luebeck, DE D-23542 |
| Contact | Frank Clanzett |
| Correspondent | Frank Clanzett DRAGER MEDIZINTECHNIK GMBH 53/55 MOISLINGER ALLEE Luebeck, DE D-23542 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-29 |
| Decision Date | 1999-03-29 |
| Summary: | summary |