NORLAND MODEL 278 BONE DENSITOMETER

Densitometer, Bone

NORLAND CORP.

The following data is part of a premarket notification filed by Norland Corp. with the FDA for Norland Model 278 Bone Densitometer.

Pre-market Notification Details

Device IDK792444
510k NumberK792444
Device Name:NORLAND MODEL 278 BONE DENSITOMETER
ClassificationDensitometer, Bone
Applicant NORLAND CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKGI  
CFR Regulation Number892.1170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-11-29
Decision Date1979-12-27

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