LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE— 510(k) K082256
Substantially EquivalentIntegrated Medical Systems, Inc.
FDA 510(k) clearance K082256 for LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE, Substantially Equivalent on 2008-09-26. Applicant: Integrated Medical Systems, Inc..
Clearance details
- Applicant
- Integrated Medical Systems, Inc.
- Product code
- Code MWI
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Signal Hill, CA, US
Adverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
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.