V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM— 510(k) K141185
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K141185 for V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM, Substantially Equivalent on 2014-06-06. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lowell, MA, US
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Adverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
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.