# K092678: Evision Data Management Software

- Pathway: 510(k) (Special)
- Applicant: Nonin Medical, Inc.
- Decided: Oct 1, 2009 after 30 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K913695 (1991). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033307: Nvision Data Management Software, Nonin Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K132402: Sensmart Model X-100 Univeral Oximetry System (2014), 3 descendants of its own
- K160865: Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso (2016), 1 descendant of its own
- K233827: OxiWear (2024), 0 descendants of its own
- K192900: H500 Multi-Sensing Oximetry System (2020), 0 descendants of its own

## Indications for use
eVISION® Data Management Software (eVISION) is an optional accessory for use with Nonin's Model 7600 Regional Oximeter System. It is intended for use by healthcare professionals when 1) transferring data from the Model 7600 to a computer in order to maintain individual records of regional oximetry data, 2) reviewing data according to user-selected parameters, and 3) generating reports.

Source page: https://510kreport.com/device/K092678
Methodology: https://510kreport.com/methodology