Niox Article No: 02-1000

by Aerocrine AB De Novo

Active United States

De Novo DEN030001

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA De NovoDENG De Novo granted · Post-NSE	NumberDEN030001	Date30 Apr 2003Decided	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA De Novo Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

De Novo

De Novo Number: DEN030001
FDA Product Code: MXA

Device Class: Class II
Regulation: 21 CFR Part 862.3080
Advisory Committee: Clinical Toxicology
FDA Decision: DENG De Novo granted

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