DISPOSABLE MEDICATION NEBULIZER— 510(k) K801867

Substantially Equivalent

Hospitax

FDA 510(k) clearance K801867 for DISPOSABLE MEDICATION NEBULIZER, Substantially Equivalent on 1980-08-20. Applicant: Hospitax. Device class: 2.

Clearance details

Applicant: Hospitax
Product code: Code LCQ
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1980-08-05
Decision date: 1980-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCQ

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K955569 — INNOFLUOR GENTAMICIN ASSAY SYSTEM1996-02-09
K945523 — COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS1995-03-09
K943550 — GENTAMICIN FPIA REAGENT SET AND CALIBRATORS1994-11-17
K905721 — OPUS GENTAMICIN1991-02-21

Recalls naming K801867

K-number listed on FDA's recall record

Z-1044-2016 — Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.Class II·Terminated·ConvaTec, Inc·20151111

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K801867.

Data sourced from openFDA. This site is unofficial and independent of the FDA.