Spaulding Electrocardiograph 2100iQ— 510(k) K150564
Substantially EquivalentSpaulding Clinical Research, LLC
FDA 510(k) clearance K150564 for Spaulding Electrocardiograph 2100iQ, Substantially Equivalent on 2015-08-12. Applicant: Spaulding Clinical Research, LLC.
Clearance details
- Applicant
- Spaulding Clinical Research, LLC
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Bend, WI, US
Adverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
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.