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510(k) K221195

OsteoProbe by Active Life Scientific, Inc. — Product Code QGQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 28, 2022
Date Received: April 25, 2022
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Bone Indentation Device
Device Class: Class II
Regulation Number: 888.1600
Review Panel: OR
Submission Type

A bone indentation device is a device that measures resistance to indentation in bone.