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510(k) DEN220048

Neoasis by Invictus Medical, Inc. — Product Code QWX

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
June 16, 2023
Date Received
July 25, 2022
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Active Noise Attenuation System For Infant Incubators
Device Class
Class II
Regulation Number
880.5405
Review Panel
HO
Submission Type

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.

Other clearances by Invictus Medical, Inc.

  • K150243 — Invictus Medical GelShield (May 1, 2015)