The following data is part of a premarket notification filed by Schick Technologies, Inc. with the FDA for Modification To Accudexa Bone Densitometer.
Device ID | K001429 |
510k Number | K001429 |
Device Name: | MODIFICATION TO ACCUDEXA BONE DENSITOMETER |
Classification | Densitometer, Bone |
Applicant | SCHICK TECHNOLOGIES, INC. 31-00 47TH AVE. Long Island, NY 11101 |
Contact | Daniel Michaeli |
Correspondent | Daniel Michaeli SCHICK TECHNOLOGIES, INC. 31-00 47TH AVE. Long Island, NY 11101 |
Product Code | KGI |
CFR Regulation Number | 892.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-05-05 |
Decision Date | 2000-05-26 |