Chrysalis Intelligence · Sponsors · Ivy Biomedical Systems, Inc.

Ivy Biomedical Systems, Inc.

Branford, CT, US · 4 510(k) clearances

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Total clearances
4
2020-03-28 → 2024-09-13
Last 12 months
0
Product codes
3
Most recent
2024-09-13
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LNH — — — 2 2021-03-02
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Class II Cardiovascular 1 2024-09-13
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Class II Cardiovascular 1 2021-05-14
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2024-09-13 K240087 RT Carbon ECG Leads DSA Class II Cardiovascular
2021-05-14 K202138 Cardiac Trigger Monitor DRT Class II Cardiovascular
2021-03-02 K203653 MRI PPG Patient Cable LNH — —
2020-03-28 K192852 MRI ECG Patient Cable LNH — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence