TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM— 510(k) K123446
Substantially EquivalentUnited States Gtm Medical Devices, Inc.
FDA 510(k) clearance K123446 for TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM, Substantially Equivalent on 2012-12-07. Applicant: United States Gtm Medical Devices, Inc..
Clearance details
- Applicant
- United States Gtm Medical Devices, Inc.
- Product code
- Code DXN
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
Adverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- 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.