FDA 510(k)

AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A

K-Number: K002758 · 2001-02-22

ApplicantAgilent Technologies Deutschland GmbH

Decision Date2001-02-22

Product CodeDSI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A is the device name listed in this FDA 510(k) record. The listed applicant is Agilent Technologies Deutschland GmbH. It received FDA 510(k) clearance on 2001-02-22 under 510(k) number K002758. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A?

AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A is a medical device that received FDA 510(k) clearance on 2001-02-22. The listed applicant is Agilent Technologies Deutschland GmbH. The 510(k) number is K002758.

When did AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A receive FDA 510(k) clearance?

AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A received FDA 510(k) clearance on 2001-02-22, under 510(k) number K002758.

Who is the listed applicant for AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A?

The FDA 510(k) record lists Agilent Technologies Deutschland GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A?

The FDA product code for AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A is DSI.

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Other records listing Agilent Technologies Deutschland GmbH as applicant

K003038AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A K001722AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE K001333AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.