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FDA 510(k)

AMBU BLUE SENSOR NEO AND NEO X

K-Number: K053550 · 2006-10-25

ApplicantAmbu A/S
Decision Date2006-10-25
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMBU BLUE SENSOR NEO AND NEO X is the device name listed in this FDA 510(k) record. The listed applicant is Ambu A/S. It received FDA 510(k) clearance on 2006-10-25 under 510(k) number K053550. 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 NEO AND NEO X?

AMBU BLUE SENSOR NEO AND NEO X is a medical device that received FDA 510(k) clearance on 2006-10-25. The listed applicant is Ambu A/S. The 510(k) number is K053550.

When did AMBU BLUE SENSOR NEO AND NEO X receive FDA 510(k) clearance?

AMBU BLUE SENSOR NEO AND NEO X received FDA 510(k) clearance on 2006-10-25, under 510(k) number K053550.

Who is the listed applicant for AMBU BLUE SENSOR NEO AND NEO X?

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

What is the FDA product code for AMBU BLUE SENSOR NEO AND NEO X?

The FDA product code for AMBU BLUE SENSOR NEO AND NEO X is DRX.

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Other records listing Ambu A/S 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.

K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeK260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetK260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)K251583Ambu® Virobac II® Exhalation FilterK250269Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2

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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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