RESPIGRAPH— 510(k) K854956

Substantially Equivalent

Respitrace Corp.

FDA 510(k) clearance K854956 for RESPIGRAPH, Substantially Equivalent on 1986-03-20. Applicant: Respitrace Corp..

Clearance details

Applicant: Respitrace Corp.
Product code: Code BZK
Advisory panel: Anesthesiology
Date received: 1985-12-11
Decision date: 1986-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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.