OP-PNEU ELECTRONIC CO2— 510(k) K941438

Substantially Equivalent

Wisap/U.S.A.

FDA 510(k) clearance K941438 for OP-PNEU ELECTRONIC CO2, Substantially Equivalent on 1995-05-11. Applicant: Wisap/U.S.A..

Clearance details

Applicant: Wisap/U.S.A.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 1994-03-24
Decision date: 1995-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Munchen,, DE

Download summary PDF View on FDA.gov ↗

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.