QWX · Class II · 21 CFR 880.5405

FDA Product Code QWX: Active Noise Attenuation System For Infant Incubators

A Device System Which Captures The Environmental Noise And Outputs Noise Cancelling Acoustic Sound Waves To Attenuate Noise In Infant Incubators In The Healthcare Environment.

Leading manufacturers include Invictus Medical, Inc..

1
Total
0
Cleared
326d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Active Noise Attenuation System For Infant Incubators Devices (Product Code QWX)

1 devices
1–1 of 1
Not Cleared Jun 16, 2023
Neoasis
DEN220048
Invictus Medical, Inc.
General Hospital · 326d

About Product Code QWX - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QWX since 2023, with 0 receiving FDA clearance (average review time: 326 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QWX devices are reviewed by the General Hospital panel. Browse all General Hospital devices →