The following data is part of a premarket notification filed by Photonic Optische Gerate Gmbh & Cokg with the FDA for Ps Series With Fiber Light Guide And Headlight, Models Ps200, Ps250, Ps500.
| Device ID | K070287 |
| 510k Number | K070287 |
| Device Name: | PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 |
| Classification | Light, Surgical Headlight |
| Applicant | PHOTONIC OPTISCHE GERATE GMBH & COKG SEEBOCKGASSE 59 Vienna, AT A-1160 |
| Contact | Dieter Feger |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | EBA |
| Subsequent Product Code | EAY |
| Subsequent Product Code | EAZ |
| CFR Regulation Number | 872.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-01-29 |
| Decision Date | 2007-02-12 |
| Summary: | summary |