Home / 510(k) Clearances / K053490

510(k) K053490

MERITS HEALTH PRODUCTS PORTABLE NEBULIZER by Merits Health Products Co., Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2006
Date Received
December 15, 2005
Clearance Type
Abbreviated
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 Merits Health Products Co., Ltd.

  • K220529 — Merits P335 Powered Wheelchair (March 18, 2022)
  • K142912 — Merits Yoga Power Scooter, S542 (June 23, 2015)
  • K142162 — MERITS TRANSFORMER POWER SCOOTER, S941 (May 1, 2015)
  • K122357 — MERITS MODEL P322FWD POWERED WHEELCHAIR (January 9, 2013)
  • K113577 — MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR (May 8, 2012)
  • K092859 — MERITS MODEL N SERIES NEBULIZER COMPRESSORS (July 2, 2010)
  • K091716 — MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY (April 2, 2010)
  • K073110 — MERITS E600 SERIES STAIR LIFT (February 6, 2008)
  • K073513 — MERITS E700 PORCE LIFT (January 14, 2008)
  • K053230 — MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS (May 16, 2006)

Other clearances for product code CAF

  • K251572 — eRapid with eTrack System (December 19, 2025)
  • 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)