MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT— 510(k) K844740
Substantially EquivalentHewlett-Packard Co.
FDA 510(k) clearance K844740 for MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT, Substantially Equivalent on 1985-02-12. Applicant: Hewlett-Packard Co.. Device class: 2.
Clearance details
- Applicant
- Hewlett-Packard Co.
- Product code
- Code LDD
- Device class
- Class 2
- Regulation
- 21 CFR 870.5300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcminnville, OR, US
Recent devices under product code LDD
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 LDD
product code LDD- Death
- 38
- Malfunction
- 522
- Total
- 560
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.