SG-066 OXYGEN ENRICHMENT KIT— 510(k) K860077

Substantially Equivalent

Instrumentation Industries, Inc.

FDA 510(k) clearance K860077 for SG-066 OXYGEN ENRICHMENT KIT, Substantially Equivalent on 1986-02-18. Applicant: Instrumentation Industries, Inc..

Clearance details

Applicant: Instrumentation Industries, Inc.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 1986-01-08
Decision date: 1986-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethel Park, PA, US

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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.