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510(k) K180407

Smartinhaler by Adherium (Nz), Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2018
Date Received
February 14, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Adherium (Nz), Ltd.

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  • K220622 — Hailie Sensor NF0106 (July 15, 2022)
  • K211233 — Hailie Sensor NF0109 (August 18, 2021)
  • K182638 — Hailie Sensor (June 19, 2019)
  • K182573 — Hailie Sensor (June 7, 2019)
  • K181405 — Hailie Sensor (December 10, 2018)
  • K173310 — SmartTouch (March 26, 2018)
  • K163485 — SmartTouch (August 30, 2017)

Other clearances for product code CAF

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  • K251659 — Mesh Nebulizer (H6) (November 14, 2025)
  • K244035 — Portable mesh nebulizer (JM821) (September 19, 2025)
  • K243468 — Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebul (July 2, 2025)
  • K250022 — HeroTracker Sense (June 30, 2025)
  • K250583 — AdheResp Smart Breath-actuated Mesh Nebulizer (June 20, 2025)
  • K242354 — AllNEB (April 29, 2025)
  • K233553 — MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter (June 18, 2024)
  • K232507 — Aerogen®Solo Nebulizer System (May 10, 2024)
  • K232523 — Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% (April 10, 2024)