The following data is part of a premarket notification filed by Gp&p Co., Ltd. with the FDA for Dcas I.
Device ID | K140869 |
510k Number | K140869 |
Device Name: | DCAS I |
Classification | System, Image Processing, Radiological |
Applicant | GP&P CO., LTD. 12226 WASHINGTON LANE Parker, AZ 85344 |
Contact | Charlie Mack |
Correspondent | Charlie Mack GP&P CO., LTD. 12226 WASHINGTON LANE Parker, AZ 85344 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-03 |
Decision Date | 2014-07-03 |
Summary: | summary |