OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067— 510(k) K992670

Name: FDA 510(k) clearance K992670
Creator: U.S. Food and Drug Administration
Published: 1999-09-17

Substantially Equivalent - Subject to Tracking Reg.

Instrumentation Industries, Inc.

FDA 510(k) clearance K992670 for OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067, Substantially Equivalent - Subject to Tracking Reg. on 1999-09-17. Applicant: Instrumentation Industries, Inc.. Device class: 2.

Clearance details

Applicant: Instrumentation Industries, Inc.
Product code: Code CBK
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 1999-06-21
Decision date: 1999-09-17
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Bethel Park, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.