Chrysalis Intelligence · Sponsors · Sibel Health, Inc.

Sibel Health, Inc.

Chicago, IL, US · 5 510(k) clearances

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Total clearances

5

2023-08-10 → 2026-02-26

Last 12 months

1

Product codes

4

Most recent

2026-02-26

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Class II	Cardiovascular	2	2024-06-03
HGM	System, Monitoring, Perinatal	Class II	Obstetrics/Gynecology	1	2026-02-26
MSX	System, Network And Communication, Physiological Monitors	Class II	Cardiovascular	1	2025-01-08
DQA	Oximeter	Class II	Cardiovascular	1	2024-05-28

Filings

All 510(k) clearances (5)

Date	K-number	Device	Code	Class	Specialty
2026-02-26	K253021	ANNE Maternal	HGM	Class II	Obstetrics/Gynecology
2025-01-08	K242842	ANNE View, Central Hub	MSX	Class II	Cardiovascular
2024-06-03	K240251	ANNE Chest	DRG	Class II	Cardiovascular
2024-05-28	K240305	ANNE Limb	DQA	Class II	Cardiovascular
2023-08-10	K223711	ANNE One	DRG	Class II	Cardiovascular