PARTIAL PRESSURE ELECTRODE MEASUREMENT— 510(k) K833536

Name: FDA 510(k) clearance K833536
Creator: U.S. Food and Drug Administration
Published: 1983-12-29

Substantially Equivalent

Shaban Mfg. Co.

FDA 510(k) clearance K833536 for PARTIAL PRESSURE ELECTRODE MEASUREMENT, Substantially Equivalent on 1983-12-29. Applicant: Shaban Mfg. Co.. Device class: 2.

Clearance details

Applicant: Shaban Mfg. Co.
Product code: Code CHL
Device class: Class 2
Regulation: 21 CFR 862.1120
Advisory panel: Clinical Chemistry
Date received: 1983-10-05
Decision date: 1983-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K853621 — REPLACEMENT PUMP TUBING1985-12-05
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K850333 — PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS1985-02-27
K844781 — MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB1985-02-01
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Adverse events under product code CHL

product code CHL

Death: 20
Malfunction: 999
Total: 1,019

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.