The following data is part of a premarket notification filed by Daito Co., Ltd. with the FDA for Radiographic Film Processor, Models Xp400 And Xp1000.
Device ID | K024342 |
510k Number | K024342 |
Device Name: | RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000 |
Classification | Processor, Radiographic-film, Automatic |
Applicant | DAITO CO., LTD. 945 MAIN ST. STE. 312 Manchester, CT 06040 |
Contact | Edward Epstein |
Correspondent | Edward Epstein DAITO CO., LTD. 945 MAIN ST. STE. 312 Manchester, CT 06040 |
Product Code | IXW |
CFR Regulation Number | 892.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-27 |
Decision Date | 2003-04-23 |
Summary: | summary |