The following data is part of a premarket notification filed by Norland Corp. with the FDA for Norland Model 278 Bone Densitometer.
Device ID | K792444 |
510k Number | K792444 |
Device Name: | NORLAND MODEL 278 BONE DENSITOMETER |
Classification | Densitometer, Bone |
Applicant | NORLAND CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KGI |
CFR Regulation Number | 892.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-29 |
Decision Date | 1979-12-27 |