PHOT-X II, MODEL 303

Unit, X-ray, Extraoral With Timer

TAKARA BELMONT USA, INC.

The following data is part of a premarket notification filed by Takara Belmont Usa, Inc. with the FDA for Phot-x Ii, Model 303.

Pre-market Notification Details

Device IDK042260
510k NumberK042260
Device Name:PHOT-X II, MODEL 303
ClassificationUnit, X-ray, Extraoral With Timer
Applicant TAKARA BELMONT USA, INC. 101 BELMONT DR. Somerset,  NJ  08873
ContactMasahiro Kanaya
CorrespondentElizabeth Drew
UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara,  CA  95050
Product CodeEHD  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-08-23
Decision Date2004-09-07
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.