AEROMIST II NEBULIZER— 510(k) K901315

Name: FDA 510(k) clearance K901315
Creator: U.S. Food and Drug Administration
Published: 1990-09-10

Substantially Equivalent

Inhalation Plastics

FDA 510(k) clearance K901315 for AEROMIST II NEBULIZER, Substantially Equivalent on 1990-09-10. Applicant: Inhalation Plastics. Device class: 2.

Clearance details

Applicant: Inhalation Plastics
Product code: Code CAF
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 1990-03-21
Decision date: 1990-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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K945565 — SPIRO-FLEX1995-01-13
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K900990 — FILT-R-ALL BACTERIAL/VIRAL FILTER1990-04-19
K900594 — ANESTHESIA BREATHING CIRCUIT1990-03-15
K896832 — FILT-R-ALL BACTERIAL FILTER1990-01-22

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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