MULTI HI-FLO PNEU, WISAP #7080— 510(k) K011510

Name: FDA 510(k) clearance K011510
Creator: U.S. Food and Drug Administration
Published: 2002-04-02

Substantially Equivalent

Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh

FDA 510(k) clearance K011510 for MULTI HI-FLO PNEU, WISAP #7080, Substantially Equivalent on 2002-04-02. Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh. Device class: 2.

Clearance details

Applicant: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 2001-05-16
Decision date: 2002-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sauerlach, DE

Download summary PDF View on FDA.gov ↗

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K031014 — HI-FLO THERME PNEU 45, WISAP #7083, 7083V2003-06-27
K992481 — CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF2000-03-17
K992513 — THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF2000-03-17
K990662 — DISPOSABLE HEATING TUBING SET #7642HSES1999-09-24
K982515 — POWER-DRIVE, WISAP MODEL #7688PD/7688PD11999-01-19

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.