HEARTSTREAM ELECTRODE ADAPTER— 510(k) K984286
Substantially EquivalentHewlett-Packard Co.
FDA 510(k) clearance K984286 for HEARTSTREAM ELECTRODE ADAPTER, Substantially Equivalent on 1998-12-17. Applicant: Hewlett-Packard Co.. Device class: 3.
Clearance details
- Applicant
- Hewlett-Packard Co.
- Product code
- Code MKJ
- Device class
- Class 3
- Regulation
- 21 CFR 870.5310
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Seattle, WA, US
Recent devices under product code MKJ
view allMore clearances from Hewlett-Packard Co.
view all- K992543 — HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE
- K993587 — HP M2376A DEVICE LINK SYSTEM
- K993169 — MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
- K992977 — HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A
- K993516 — HP M2600A VIRIDIA TELEMETRY SYSTEM
Adverse events under product code MKJ
product code MKJ- Death
- 961
- Injury
- 1,070
- Malfunction
- 90,719
- Other
- 8
- Total
- 92,758
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.