Novaerus NV1050— 510(k) K200321

Substantially Equivalent

Novaerus Us, Inc.

FDA 510(k) clearance K200321 for Novaerus NV1050, Substantially Equivalent on 2020-12-28. Applicant: Novaerus Us, Inc.. Device class: 2.

Clearance details

Applicant
Novaerus Us, Inc.
Product code
Code FRF
Device class
Class 2
Regulation
21 CFR 880.5045
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Stamford, CT, US
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