AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154— 510(k) K011093
Substantially EquivalentAgilent Technologies, Inc.
FDA 510(k) clearance K011093 for AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154, Substantially Equivalent on 2001-05-01. Applicant: Agilent Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Agilent Technologies, Inc.
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Andover, MA, US
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Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
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.