RESUSCITATOR MODELS 10400/10500/10600/10700/10800— 510(k) K862192

Name: FDA 510(k) clearance K862192
Creator: U.S. Food and Drug Administration
Published: 1986-07-07

Substantially Equivalent

U.O. Equipment Co.

FDA 510(k) clearance K862192 for RESUSCITATOR MODELS 10400/10500/10600/10700/10800, Substantially Equivalent on 1986-07-07. Applicant: U.O. Equipment Co.. Device class: 2.

Clearance details

Applicant: U.O. Equipment Co.
Product code: Code BTL
Device class: Class 2
Regulation: 21 CFR 868.5925
Advisory panel: Anesthesiology
Date received: 1986-06-09
Decision date: 1986-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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More clearances from U.O. Equipment Co.

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K862194 — INHALATOR MODELS 8100, 10100 AND 102001986-07-28
K862193 — # 10099/10225/10235/10275/10525/10625/10715/101251986-07-09

Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.