The following data is part of a premarket notification filed by Drager Medical Gmbh with the FDA for Polaris 100/200.
| Device ID | K123776 |
| 510k Number | K123776 |
| Device Name: | POLARIS 100/200 |
| Classification | Lamp, Surgical |
| Applicant | DRAGER MEDICAL GMBH 6 TECH DRIVE Andover, MA 01810 |
| Contact | Beth Zis |
| Correspondent | Beth Zis DRAGER MEDICAL GMBH 6 TECH DRIVE Andover, MA 01810 |
| Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-10 |
| Decision Date | 2013-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675295495 | K123776 | 000 |
| 04048675268109 | K123776 | 000 |