AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE— 510(k) K001722

Substantially Equivalent

Agilent Technologies Deutschland GmbH

FDA 510(k) clearance K001722 for AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE, Substantially Equivalent on 2000-06-30. Applicant: Agilent Technologies Deutschland GmbH. Device class: 2.

Clearance details

Applicant
Agilent Technologies Deutschland GmbH
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
Boeblingen,, DE
Download summary PDFView on FDA.gov ↗

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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.