The following data is part of a premarket notification filed by Datacom Technology Corp. with the FDA for Datacom Dc Pacs.
Device ID | K083182 |
510k Number | K083182 |
Device Name: | DATACOM DC PACS |
Classification | System, Image Processing, Radiological |
Applicant | DATACOM TECHNOLOGY CORP. NO.58, FU CHIUN STREET Hsin Chu City Tw-hsq Taiwan, CN 30067 |
Contact | Jen Ke-min |
Correspondent | Jen Ke-min DATACOM TECHNOLOGY CORP. NO.58, FU CHIUN STREET Hsin Chu City Tw-hsq Taiwan, CN 30067 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-10-28 |
Decision Date | 2009-03-04 |
Summary: | summary |