TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT— 510(k) K062342
Substantially EquivalentSentra Medical Devices, LLC
FDA 510(k) clearance K062342 for TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT, Substantially Equivalent on 2006-09-25. Applicant: Sentra Medical Devices, LLC.
Clearance details
- Applicant
- Sentra Medical Devices, LLC
- Product code
- Code DRS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Canton, MI, 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.