RESPITRACE 300SC— 510(k) K823780

Name: FDA 510(k) clearance K823780
Creator: U.S. Food and Drug Administration
Published: 1984-01-20

Substantially Equivalent

Respitrace Corp.

FDA 510(k) clearance K823780 for RESPITRACE 300SC, Substantially Equivalent on 1984-01-20. Applicant: Respitrace Corp.. Device class: 2.

Clearance details

Applicant: Respitrace Corp.
Product code: Code BZK
Device class: Class 2
Regulation: 21 CFR 868.1850
Advisory panel: Anesthesiology
Date received: 1982-12-15
Decision date: 1984-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ardsley, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BZK

product code BZK

Death: 2
Total: 2

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.