NIFA NON INVASIVE FLUTTER ASSEMBLY— 510(k) K844853

Name: FDA 510(k) clearance K844853
Creator: U.S. Food and Drug Administration
Published: 1985-12-12

Substantially Equivalent

Emergency Management Products, Inc.

FDA 510(k) clearance K844853 for NIFA NON INVASIVE FLUTTER ASSEMBLY, Substantially Equivalent on 1985-12-12. Applicant: Emergency Management Products, Inc.. Device class: 2.

Clearance details

Applicant: Emergency Management Products, Inc.
Product code: Code KDQ
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1984-12-14
Decision date: 1985-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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Recent devices under product code KDQ

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K081718 — EXPRESS CHEST DRAIN2008-07-25
K062302 — MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM2006-10-06
K043582 — OCEAN CHEST DRAIN2005-01-21
K984496 — ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN1999-05-05
K962856 — PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR1996-08-28

Adverse events under product code KDQ

product code KDQ

Death: 8
Malfunction: 637
Total: 645

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.