ONGUARD 1000, CATALOG #043611-000 & 043611-001— 510(k) K870976

Name: FDA 510(k) clearance K870976
Creator: U.S. Food and Drug Administration
Published: 1987-05-06

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K870976 for ONGUARD 1000, CATALOG #043611-000 & 043611-001, Substantially Equivalent on 1987-05-06. Applicant: Cobe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code DTQ
Device class: Class 2
Regulation: 21 CFR 870.4220
Advisory panel: Cardiovascular
Date received: 1987-03-10
Decision date: 1987-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

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.