K070710
Substantially EquivalentACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM
- Applicant
- Biosensors International-USA
- Product code
- DRS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Newport Beach, CA, US
Adverse events under product code DRS
product code DRS- Death
- 8
- Malfunction
- 776
- Total
- 784
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.