The following data is part of a premarket notification filed by Drager Medizintechnik Gmbh with the FDA for Sola 700,sola 500, Sola 300.
| Device ID | K010724 |
| 510k Number | K010724 |
| Device Name: | SOLA 700,SOLA 500, SOLA 300 |
| Classification | Lamp, Surgical |
| Applicant | DRAGER MEDIZINTECHNIK GMBH 3135 QUARRY RD. Telford, PA 18969 |
| Contact | James J Brennan |
| Correspondent | James J Brennan DRAGER MEDIZINTECHNIK GMBH 3135 QUARRY RD. Telford, PA 18969 |
| Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-12 |
| Decision Date | 2001-06-07 |