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510(k) K100380

ALTERA NEBULIZER SYSTEM, MODEL 678G1002 by Pari Respiratory Equipment, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2010
Date Received
February 16, 2010
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 Pari Respiratory Equipment, Inc.

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  • K162785 — Velox Nebulizer System (April 14, 2017)
  • K150044 — O-PEP (May 27, 2016)
  • K112859 — ERAPID NEBULIZER SYSTEM (May 30, 2012)
  • K092560 — PARI SINUS (May 6, 2010)
  • K092918 — PARI VIOS (February 4, 2010)
  • K090829 — PARI PEP S (July 21, 2009)

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)