TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM— 510(k) K904690

Substantially Equivalent

Marquest Medical Products, Inc.

FDA 510(k) clearance K904690 for TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM, Substantially Equivalent on 1991-02-01. Applicant: Marquest Medical Products, Inc..

Clearance details

Applicant
Marquest Medical Products, Inc.
Product code
Code DWJ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Englewood, CO, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DWJ

product code DWJ
Death
7
Injury
679
Malfunction
17,477
Total
18,163

Source: openFDA MAUDE database, through . 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.