KELLER PULSE OXIMETER, MODEL 850+— 510(k) K982331

Substantially Equivalent

Keller Medical Specialties Products, Inc.

FDA 510(k) clearance K982331 for KELLER PULSE OXIMETER, MODEL 850+, Substantially Equivalent on 1998-09-11. Applicant: Keller Medical Specialties Products, Inc..

Clearance details

Applicant: Keller Medical Specialties Products, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1998-07-02
Decision date: 1998-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Antioch, IL, 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.