The following data is part of a premarket notification filed by Takara Belmont Usa, Inc. with the FDA for Phot-x Ii, Model 303.
Device ID | K042260 |
510k Number | K042260 |
Device Name: | PHOT-X II, MODEL 303 |
Classification | Unit, X-ray, Extraoral With Timer |
Applicant | TAKARA BELMONT USA, INC. 101 BELMONT DR. Somerset, NJ 08873 |
Contact | Masahiro Kanaya |
Correspondent | Elizabeth Drew UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
Product Code | EHD |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2004-08-23 |
Decision Date | 2004-09-07 |
Summary: | summary |