Home / 510(k) Clearances / K841158

510(k) K841158

NEBULO 28 NEBULIZER KIT by Inspiron Corp. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1984
Date Received
March 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
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)
  • 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)
  • K772068 — MANIFOLD & NEBULIZER, UNIVERSAL (November 15, 1977)
  • K772071 — MANIFOLD & NEBU. FOR SINGLE LINE MACH. (November 15, 1977)

Other clearances for product code BTT

  • K251448 — FL-10000U Respiratory Humidifier (January 16, 2026)
  • K251419 — Laboratorios Biogalenic Sterile Water for Inhalation, USP (January 14, 2026)
  • K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) (December 19, 2025)
  • K250312 — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo (July 2, 2025)
  • K251611 — Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT (June 25, 2025)
  • K242717 — Laboratorios Biogalenic Sterile Water for Inhalation, USP (January 30, 2025)
  • K241778 — Hudson RCI Comfort Flo® CubCannula™ (December 19, 2024)
  • K240163 — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (September 27, 2024)
  • K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041 (August 8, 2024)
  • K233707 — HFT150 (June 14, 2024)