MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A— 510(k) K001776
Substantially EquivalentAgilent Technologies, Inc.
FDA 510(k) clearance K001776 for MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A, Substantially Equivalent on 2000-06-30. Applicant: Agilent Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Agilent Technologies, Inc.
- Product code
- Code MWI
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Andover, MA, US
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- K010634 — HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B
- K011578 — M2376A DEVICELINK SYSTEM, MODEL M2376A
Adverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
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.