Home / 510(k) Clearances / K772068

510(k) K772068

MANIFOLD & NEBULIZER, UNIVERSAL by Inspiron Corp. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1977
Date Received
November 1, 1977
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 Inspiron Corp.

  • K860838 — INSPIRON DOUBLE SWIVEL TRACH ADAPTER (April 9, 1986)
  • K850346 — OXYGEN CONCENTRATOR (February 4, 1985)
  • K843932 — VAPOR-PHASE HUMIDIFIER SYS-ADVANCED (October 18, 1984)
  • K840935 — MANUAL RESUSCITATION SYSTEM (April 5, 1984)
  • K841158 — NEBULO 28 NEBULIZER KIT (March 30, 1984)
  • K840418 — INSPIRATORY/EXPIRATORY MUSCLE EXERCIS (February 17, 1984)
  • K834290 — INSPIRON LIQUID OXYGEN SYSTEM (February 4, 1984)
  • K772070 — VENTILATOR SETUP, VOLUME (November 15, 1977)
  • K772072 — MANIFOLD & NEBU. FOR DOUB. LINE MACH. (November 15, 1977)
  • K772071 — MANIFOLD & NEBU. FOR SINGLE LINE MACH. (November 15, 1977)

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)