MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)
ImpediMed Limited · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Lindfield
- Advisory committee description
- Cardiovascular
- Address 1
- Suite 31c
- Address 2
- 12-18 Tryon Rd.
- Statement or summary
- Summary
- Product code
- DSB
- Zip code
- 2070
- Applicant
- ImpediMed Limited
- Decision date
- 2026-08-17
- Decision code
- SESE
- Country code
- AU
- Device name
- MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)
- Advisory committee
- CV
- Contact
- Richard Hines
- K number
- K260224
- Date received
- 2026-01-26
- Review advisory committee
- GU
- Postal code
- 2070
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Plethysmograph, Impedance
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.2770
- Device class
- 2
- Registration number
- 3016701404, 1316463, 2025475, 1018233, 9680010, 3023272766, 3003695829, 3003832357, 3008483389, 3010097171, 3045891669, 3006082230, 9681449, 3005783425, 3011773282, 3042941992, 3009156722, 2648045, 3021242837, 9610105, 3009077524, 3014158038, 2027046, 3006113127, 3008240972, 3016618143, 3007836437, 9615817, 1000610255, 3003174284, 3018940143, 3002684743, 3007603826, 1219324, 3003857828, 3003803088, 3013596024, 1317188, 3004987887, 9610816 +28 more
- FEI number
- 3016701404, 1316463, 2025475, 1018233, 3023272766, 3003695829, 3003832357, 3001451571, 3008483389, 3010097171, 3003081151, 3045891669, 3006082230, 3002087856, 3005783425, 3001726808, 3011773282, 3042941992, 3009156722, 2648045, 3021242837, 3009077524, 3014158038, 2027046, 3006113127, 3008240972, 3016618143, 3007836437, 1000610255, 3003174284, 3018940143, 3002684743, 3007603826, 1219324, 3003857828, 3003803088, 3013596024, 1317188, 3004987887, 3019130 +28 more