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Nivo Nebulizer System

by Aerogen (Ireland), Ltd. Ireland 510(k)

510(k) K102240 Product code CAF

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK102240 Date10 Nov 2010ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
CAF
FDA applicant
Aerogen Ireland, Ltd.
Device Class
Class II
Regulation
21 CFR Part 868.5630
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Aerogen (Ireland), Ltd.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K102240 24 fields · synced 22 Oct 2026