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FDA 510(k)

AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S

K-Number: K041026 · 2004-06-28

ApplicantAmbu, Inc.
Decision Date2004-06-28
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S is the device name listed in this FDA 510(k) record. The listed applicant is Ambu, Inc.. It received FDA 510(k) clearance on 2004-06-28 under 510(k) number K041026. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S?

AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S is a medical device that received FDA 510(k) clearance on 2004-06-28. The listed applicant is Ambu, Inc.. The 510(k) number is K041026.

When did AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S receive FDA 510(k) clearance?

AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S received FDA 510(k) clearance on 2004-06-28, under 510(k) number K041026.

Who is the listed applicant for AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S?

The FDA 510(k) record lists Ambu, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S?

The FDA product code for AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S is DRX.

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Other records listing Ambu, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K051529AMBU NEUROLINE GROUNDK042682AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATORK042843AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORSK041734AMBU DISPOSABLE ECG ELECTRODEK040991AMBU DISPOSABLE PRESSURE MANOMETERK032278AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE

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Related Devices (Code: DRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

Official Source

View on FDA Database →

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

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