SIDESTREAM PUMP PLUG-IN MODULE OF COMPONENT MONITORING SYSTEM— 510(k) K943389
Substantially EquivalentHewlett-Packard Co.
FDA 510(k) clearance K943389 for SIDESTREAM PUMP PLUG-IN MODULE OF COMPONENT MONITORING SYSTEM, Substantially Equivalent on 1995-03-17. Applicant: Hewlett-Packard Co.. Device class: 2.
Clearance details
- Applicant
- Hewlett-Packard Co.
- Product code
- Code CCK
- Device class
- Class 2
- Regulation
- 21 CFR 868.1400
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MS, US
Recent devices under product code CCK
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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 CCK
product code CCK- Death
- 3
- Malfunction
- 11,428
- Total
- 11,431
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.