ION SELECTIVE ELECTRODE SUBSYSTEM OF PARA. ANALYT.— 510(k) K882104

Substantially Equivalent

Paramax Systems Div. Baxter Healthcare

FDA 510(k) clearance K882104 for ION SELECTIVE ELECTRODE SUBSYSTEM OF PARA. ANALYT., Substantially Equivalent on 1988-07-05. Applicant: Paramax Systems Div. Baxter Healthcare.

Clearance details

Applicant: Paramax Systems Div. Baxter Healthcare
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 1988-05-19
Decision date: 1988-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

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.