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