510(k) K232089
K232089 is an FDA 510(k) premarket notification submitted by ImpediMed Limited for the device "SOZO Pro". The FDA issued a decision of Substantially Equivalent on October 17, 2023. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. ImpediMed Limited has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2023
- Date Received
- July 13, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plethysmograph, Impedance
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- CV
- Submission Type