OHIO THORACIC COLLECTION UNIT— 510(k) K801942

Name: FDA 510(k) clearance K801942
Creator: U.S. Food and Drug Administration
Published: 1980-09-16

Substantially Equivalent

Ohio Medical Products

FDA 510(k) clearance K801942 for OHIO THORACIC COLLECTION UNIT, Substantially Equivalent on 1980-09-16. Applicant: Ohio Medical Products. Device class: 2.

Clearance details

Applicant: Ohio Medical Products
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1980-08-13
Decision date: 1980-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ohio Medical Products

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K841733 — OHIO WASTE GAS SCAVENGING RESERVOIR1984-07-11
K842003 — OHIO WASTE GAS SCAVENGING INTERFACE1984-05-23
K840356 — OHIO UNITROL II ANESTHESIA GAS MACHINE1984-04-20
K841274 — BAG-TO-VENTILATOR SELECTOR VALVE1984-04-13
K840857 — OHIO 3000 INFANT WARMER SYSTEM1984-03-23

Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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.