MONITOR, RESP. OXYGEN (TOP)— 510(k) K760338

Name: FDA 510(k) clearance K760338
Creator: U.S. Food and Drug Administration
Published: 1976-08-11

Substantially Equivalent

Sherwood Medical Industries

FDA 510(k) clearance K760338 for MONITOR, RESP. OXYGEN (TOP), Substantially Equivalent on 1976-08-11. Applicant: Sherwood Medical Industries. Device class: 2.

Clearance details

Applicant: Sherwood Medical Industries
Product code: Code CCL
Device class: Class 2
Regulation: 21 CFR 868.1720
Advisory panel: Anesthesiology
Date received: 1976-07-30
Decision date: 1976-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K221734 — Maxtec MaxO2 ME+p2023-04-01
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K792013 — LANCER L-INA HUMAN REFERENCE SERUM1979-11-13
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Adverse events under product code CCL

product code CCL

Other: 2
Total: 2

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.