DIVE AND SHALLOW AND GRAND DIVE— 510(k) K072757

Name: FDA 510(k) clearance K072757
Creator: U.S. Food and Drug Administration
Published: 2008-02-08

Substantially Equivalent

Summit TO Sea

FDA 510(k) clearance K072757 for DIVE AND SHALLOW AND GRAND DIVE, Substantially Equivalent on 2008-02-08. Applicant: Summit TO Sea. Device class: 2.

Clearance details

Applicant: Summit TO Sea
Product code: Code CBF
Device class: Class 2
Regulation: 21 CFR 868.5470
Advisory panel: Anesthesiology
Date received: 2007-09-27
Decision date: 2008-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mound, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CBF

product code CBF

Death: 6
Total: 6

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.