eClinics— 510(k) K260075
Substantially EquivalentCeiba Healthcare US, Inc.
FDA 510(k) clearance K260075 for eClinics, Substantially Equivalent on 2026-10-07. Applicant: Ceiba Healthcare US, Inc.. Device class: 2.
Summary
eClinics from Ceiba Healthcare is filed under MSX, network and communication systems for physiological monitors. The name is generic, and the record doesn't say which monitors it connects to or what data it handles.
Class II, 21 CFR 870.2300. The Cardiovascular panel reviewed it as a Traditional 510(k).
Ceiba Healthcare US filed from New York, New York. Review took 268 days (January 12 to October 7, 2026).
Clearance details
- Applicant
- Ceiba Healthcare US, Inc.
- Product code
- Product code MSX
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code MSX
view allAdverse events under product code MSX
product code MSX- Death
- 59
- Total
- 59
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.