DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400— 510(k) K992638

Name: FDA 510(k) clearance K992638
Creator: U.S. Food and Drug Administration
Published: 2000-02-24

Substantially Equivalent

Critikon Company, LLC

FDA 510(k) clearance K992638 for DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400, Substantially Equivalent on 2000-02-24. Applicant: Critikon Company, LLC. Device class: 2.

Clearance details

Applicant: Critikon Company, LLC
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1999-08-06
Decision date: 2000-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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K002248 — DINAMAP PRO 1000 MONITOR, MODEL 10002000-09-21
K000500 — DINAMAP ADVANCED NIBP MODULE2000-05-26
K982342 — DINAMAP MPS SELECT PORTABLE MONITOR1998-08-14
K943709 — DINAMAP PLUS VITAL SIGNS MONOITOR1995-06-16
K942700 — DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/93401995-03-01

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.