Tester, Acoustic, Bone Quality

Device Code: 5441

Product Code(s): NAN

Device Classification Information

• Device Type ID: 5441
• Device Name: Tester, Acoustic, Bone Quality
• Review Panel: Radiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: PMA
• FDA Device Classification: Class 3 Medical Device
• Product Code: NAN
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 5441
• Device: Tester, Acoustic, Bone Quality
• Product Code: NAN
• FDA Device Classification: Class 3 Medical Device

TPLC Last Update: 2019-04-02 21:06:18