The following data is part of a premarket notification filed by Cdp, Ltd. with the FDA for Cdp 5000, Media And Distribution Center, Diagnet.
Device ID | K072960 |
510k Number | K072960 |
Device Name: | CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET |
Classification | System, Image Processing, Radiological |
Applicant | CDP, LTD. 23 EFAL STREET P.O. BOX 3325 Kiriat Arie, Petach Tikva, IL 49130 |
Contact | Doron David |
Correspondent | Harry Van Vugt KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-10-19 |
Decision Date | 2007-11-08 |
Summary: | summary |