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 |