The following data is part of a premarket notification filed by Takara Belmont Usa, Inc. with the FDA for Adr Plus Ssxi Imaging Device For X-ray Systems Such As X-caliber, X-caliber Cm, Ana-bel And Ana-bel Cm.
Device ID | K041834 |
510k Number | K041834 |
Device Name: | ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM |
Classification | System, X-ray, Extraoral Source, Digital |
Applicant | TAKARA BELMONT USA, INC. 1129 BLOOMFIELD AVENUE West Caldwell, NJ 07006 |
Contact | Robert Schiff |
Correspondent | Robert Schiff TAKARA BELMONT USA, INC. 1129 BLOOMFIELD AVENUE West Caldwell, NJ 07006 |
Product Code | MUH |
Subsequent Product Code | EHD |
Subsequent Product Code | MQB |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-07-07 |
Decision Date | 2004-12-03 |