SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS— 510(k) K953351

Substantially Equivalent

Seatronics Co.

FDA 510(k) clearance K953351 for SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS, Substantially Equivalent on 1995-10-16. Applicant: Seatronics Co..

Clearance details

Applicant: Seatronics Co.
Product code: Code CCL
Advisory panel: Anesthesiology
Date received: 1995-07-17
Decision date: 1995-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatboro, PA, US

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Adverse events under product code CCL

product code CCL

Other: 2
Total: 2

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.