The following data is part of a premarket notification filed by Photonic Optische Gerate Gesmbh & Cokg with the FDA for Ps Series.
| Device ID | K061622 |
| 510k Number | K061622 |
| Device Name: | PS SERIES |
| Classification | Image, Illumination, Fiberoptic, For Endoscope |
| Applicant | PHOTONIC OPTISCHE GERATE GESMBH & COKG SEEBOCKGASSE 59 Vienna, AT A-1160 |
| Contact | Dieter Feger |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | FFS |
| Subsequent Product Code | FCW |
| Subsequent Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-06-12 |
| Decision Date | 2007-03-05 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PS SERIES 85832664 not registered Dead/Abandoned |
Axens 2013-01-25 |