SOZO

Plethysmograph, Impedance

ImpediMed Limited

The following data is part of a premarket notification filed by Impedimed Limited with the FDA for Sozo.

Pre-market Notification Details

• Device ID: K190529
• 510k Number: K190529
• Device Name: SOZO
• Classification: Plethysmograph, Impedance
• Applicant: ImpediMed Limited Unit 1, 50 Parker Court Pinkenba, AU 4008
• Contact: Catherine Kingsford
• Correspondent: Reuben Lawson; ImpediMed, Inc. 5900 Pasteur Court, Unit 125 Carlsbad, CA 92008
• Product Code: DSB
• CFR Regulation Number: 870.2770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-03-04
• Decision Date: 2019-11-25
• Summary: summary