MODEL 8604 OXYGEN/PULSE MONITOR— 510(k) K860051

Substantially Equivalent

Nonin Medical, Inc.

FDA 510(k) clearance K860051 for MODEL 8604 OXYGEN/PULSE MONITOR, Substantially Equivalent on 1986-06-05. Applicant: Nonin Medical, Inc..

Clearance details

Applicant: Nonin Medical, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1986-01-06
Decision date: 1986-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White Bear Lake, MN, US

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Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.