CAPNOSAT— 510(k) K942849

Name: FDA 510(k) clearance K942849
Creator: U.S. Food and Drug Administration
Published: 1995-02-21

Substantially Equivalent

Spegas Industries, Ltd.

FDA 510(k) clearance K942849 for CAPNOSAT, Substantially Equivalent on 1995-02-21. Applicant: Spegas Industries, Ltd.. Device class: 2.

Clearance details

Applicant: Spegas Industries, Ltd.
Product code: Code CCK
Device class: Class 2
Regulation: 21 CFR 868.1400
Advisory panel: Anesthesiology
Date received: 1994-06-16
Decision date: 1995-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jerusalem, IL

Download summary PDF View on FDA.gov ↗

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K964239 — COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER1997-05-09
K950387 — GEMINI1995-05-03
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K933707 — CAPNODIG1993-10-27

Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

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.