SPIRO-FLEX— 510(k) K945565

Name: FDA 510(k) clearance K945565
Creator: U.S. Food and Drug Administration
Published: 1995-01-13

Substantially Equivalent

Inhalation Plastics

FDA 510(k) clearance K945565 for SPIRO-FLEX, Substantially Equivalent on 1995-01-13. Applicant: Inhalation Plastics. Device class: 1.

Clearance details

Applicant: Inhalation Plastics
Product code: Code CAI
Device class: Class 1
Regulation: 21 CFR 868.5240
Advisory panel: Anesthesiology
Date received: 1994-09-16
Decision date: 1995-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAI

product code CAI

Malfunction: 869
Other: 1
Total: 870

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.