UNIT, LIQUID, OXYGEN, PORTABLE— 510(k) K813453

Substantially Equivalent

Pensee Medical Corp.

FDA 510(k) clearance K813453 for UNIT, LIQUID, OXYGEN, PORTABLE, Substantially Equivalent on 1982-01-12. Applicant: Pensee Medical Corp..

Clearance details

Applicant: Pensee Medical Corp.
Product code: Code BYJ
Advisory panel: Anesthesiology
Date received: 1981-12-10
Decision date: 1982-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code BYJ

product code BYJ

Death: 16
Total: 16

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.