SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR— 510(k) K962683

Substantially Equivalent

Deknatel, Inc.

FDA 510(k) clearance K962683 for SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR, Substantially Equivalent on 1997-01-10. Applicant: Deknatel, Inc..

Clearance details

Applicant: Deknatel, Inc.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 1996-07-10
Decision date: 1997-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.