DeviceClearance

Product code QVC— Anesthesiology

Syncron-E

Classification name
Ventilator Waveform Analysis Software
Device class
Class 2
Regulation
21 CFR 868.5896
Advisory panel
Anesthesiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Ventilator waveform analysis software is a prescription device that uses software algorithms to analyze mechanical ventilation waveform data to detect, display, and summarize patient-ventilator interactions. The device provides results to healthcare providers as an aid to monitoring or clinical assessment.”

— U.S. Food and Drug Administration, device classification record for product code QVC under 21 CFR 868.5896, via openFDA

Market context for product code QVC

FDA has cleared 1 device under product code QVC, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QVC

Recent clearances under product code QVC

Data sourced from openFDA. This site is unofficial and independent of the FDA.