The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Hologic Models Blk-1, Dpa/qdr-1 & Qct-1.
Device ID | K871446 |
510k Number | K871446 |
Device Name: | HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1 |
Classification | Densitometer, Bone |
Applicant | HOLOGIC, INC. 590 LINCOLN ST. Waltham, MA 02154 |
Contact | Alan Hochberg |
Correspondent | Alan Hochberg HOLOGIC, INC. 590 LINCOLN ST. Waltham, MA 02154 |
Product Code | KGI |
CFR Regulation Number | 892.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-13 |
Decision Date | 1987-10-20 |