Chrysalis Intelligence · Product Codes · DSB

DSB · Plethysmograph, Impedance

Cardiovascular · 10 clearances · 6 unique sponsors

Device class
Class II
Regulation 870.2770
Total clearances
10
2020-02-21 → 2026-08-17
Last 12 months
3
Unique sponsors
6
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.2770
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
ImpediMed Limited 4 1 2026-08-17
Zynex Medical, Inc. 2 0 2023-06-16
Cardioset Medical , Ltd. 1 0 2025-09-09
Bodyport, Inc. 1 0 2022-07-29
Mode Sensors AS 1 1 2025-10-16
Fresenius Medical Care Renal Therapies Group, LLC 1 1 2025-11-24
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
93000 CPT — Medium Impedance plethysmography used for cardiac output and hemodynamic monitoring
93041 CPT — Medium Rhythm strip interpretation; cardiac impedance measurement support
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-17 K260224 ImpediMed Limited MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)
2025-11-24 K250634 Fresenius Medical Care Renal Therapies Group, LLC BCM2-Body Composition Monitor
2025-10-16 K243727 Mode Sensors AS Re:Balans
2025-09-09 K250922 Cardioset Medical , Ltd. Edema Guard Monitor (EGM) CardioSet-001
2023-10-17 K232089 ImpediMed Limited SOZO Pro
2023-06-16 K223217 Zynex Medical, Inc. Zynex Monitoring System, Model CM-1600
2022-07-29 K211585 Bodyport, Inc. Bodyport Cardiac Scale
2021-04-19 K203473 ImpediMed Limited SOZO
2020-10-02 K193410 ImpediMed Limited SOZO Body Fluid Analyzer
2020-02-21 K191697 Zynex Medical, Inc. Cardiac Monitor 1500