The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Pediatric Reference Database.
Device ID | K041266 |
510k Number | K041266 |
Device Name: | PEDIATRIC REFERENCE DATABASE |
Classification | Densitometer, Bone |
Applicant | HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
Contact | Ana Randall |
Correspondent | Ana Randall HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
Product Code | KGI |
CFR Regulation Number | 892.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-05-12 |
Decision Date | 2004-08-11 |
Summary: | summary |