510(k) K203473
K203473 is an FDA 510(k) premarket notification submitted by ImpediMed Limited for the device "SOZO". The FDA issued a decision of Substantially Equivalent on April 19, 2021. 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
- April 19, 2021
- Date Received
- November 25, 2020
- 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