Home / 510(k) Clearances / K963924

510(k) K963924

LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70 by Pari Holding Co. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1996
Date Received
September 30, 1996
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 Holding Co.

  • K002862 — PRONEB ULTRA MODEL NUMBER 85B0100 (March 13, 2001)
  • K983308 — RC CORNET, MODEL #44F50 (June 4, 1999)
  • K972042 — PARI PEP THERAPY SYSTEM (August 5, 1997)
  • K962072 — PRONEB TURBO COMPRESSOR MODEL 38V0200 (August 21, 1996)
  • K960675 — WALKHALER PORTABLE COMPRESSOR MODEL 45F70 (May 17, 1996)
  • K935540 — PARI-MASTER MODIFICATION (March 17, 1995)
  • K944152 — PARI BABY (November 18, 1994)

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)