OHIO 3000 INFANT WARMER SYSTEM— 510(k) K840857

Name: FDA 510(k) clearance K840857
Creator: U.S. Food and Drug Administration
Published: 1984-03-23

Substantially Equivalent

Ohio Medical Products

FDA 510(k) clearance K840857 for OHIO 3000 INFANT WARMER SYSTEM, Substantially Equivalent on 1984-03-23. Applicant: Ohio Medical Products. Device class: 2.

Clearance details

Applicant: Ohio Medical Products
Product code: Code FMT
Device class: Class 2
Regulation: 21 CFR 880.5130
Advisory panel: General Hospital
Date received: 1984-02-24
Decision date: 1984-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K841733 — OHIO WASTE GAS SCAVENGING RESERVOIR1984-07-11
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K840356 — OHIO UNITROL II ANESTHESIA GAS MACHINE1984-04-20
K841274 — BAG-TO-VENTILATOR SELECTOR VALVE1984-04-13
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Adverse events under product code FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

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.