510(k) K946039— MODEL #5000 PULMO PLUS
Substantially EquivalentInternational Medical Systems
Clearance details
- Applicant
- International Medical Systems
- Product code
- Code BTI
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Des Molnes, IA, US
Adverse events under product code BTI
product code BTI- Death
- 25
- Malfunction
- 1,168
- Total
- 1,193
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.