CARDIOPHONE— 510(k) K781973
Substantially EquivalentNorth American Motronic
FDA 510(k) clearance K781973 for CARDIOPHONE, Substantially Equivalent on 1979-03-21. Applicant: North American Motronic. Device class: 3.
Clearance details
- Applicant
- North American Motronic
- Product code
- Code DXY
- Device class
- Class 3
- Regulation
- 21 CFR 870.3610
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code DXY
view all- K993434 — PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
- K970072 — OPUS S MODEL 4121 AND 4124 PACEMAKERS
- K945627 — PIKOS LP 01, PIKOS LP E01
- K953866 — MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
- K954092 — ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
Adverse events under product code DXY
product code DXY- Death
- 240
- Injury
- 2,328
- Malfunction
- 2,096
- Total
- 4,664
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.