OXEQUIP CONDUCTIVE & NON ANES. BREATH— 510(k) K812624

Name: FDA 510(k) clearance K812624
Creator: U.S. Food and Drug Administration
Published: 1981-10-26

Substantially Equivalent

Oxequip Health Ind.

FDA 510(k) clearance K812624 for OXEQUIP CONDUCTIVE & NON ANES. BREATH, Substantially Equivalent on 1981-10-26. Applicant: Oxequip Health Ind.. Device class: 1.

Clearance details

Applicant: Oxequip Health Ind.
Product code: Code CAI
Device class: Class 1
Regulation: 21 CFR 868.5240
Advisory panel: Anesthesiology
Date received: 1981-09-15
Decision date: 1981-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, 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.