M2376A DEVICELINK SYSTEM— 510(k) K010048
Substantially EquivalentAgilent Technologies, Inc.
FDA 510(k) clearance K010048 for M2376A DEVICELINK SYSTEM, Substantially Equivalent on 2001-02-01. 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
- Traditional
- Location
- Andover, MA, US
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- 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.