MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500— 510(k) K001930

Substantially Equivalent

Nonin Medical, Inc.

FDA 510(k) clearance K001930 for MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500, Substantially Equivalent on 2000-07-20. Applicant: Nonin Medical, Inc..

Clearance details

Applicant: Nonin Medical, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2000-06-26
Decision date: 2000-07-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, 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.