MODEL 3500 MR-COMPATIBLE PULSE OXIMETER— 510(k) K924285

Substantially Equivalent

Magnetic Resonance Equipment Corp.

FDA 510(k) clearance K924285 for MODEL 3500 MR-COMPATIBLE PULSE OXIMETER, Substantially Equivalent on 1993-05-11. Applicant: Magnetic Resonance Equipment Corp..

Clearance details

Applicant: Magnetic Resonance Equipment Corp.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1992-08-25
Decision date: 1993-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bay Shore, NY, 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.