CARDIOPLEGIA RECIRCULATION SYS-BL 705/A— 510(k) K831458
Substantially EquivalentElectromedics, Inc.
FDA 510(k) clearance K831458 for CARDIOPLEGIA RECIRCULATION SYS-BL 705/A, Substantially Equivalent on 1983-10-20. Applicant: Electromedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Electromedics, Inc.
- Product code
- Code DWB
- Device class
- Class 2
- Regulation
- 21 CFR 870.4370
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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More clearances from Electromedics, Inc.
view allAdverse events under product code DWB
product code DWB- Death
- 2
- Total
- 2
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.