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FDA 510(k)

AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X

K-Number: K100129 · 2010-06-11

ApplicantAmbu A/S
Decision Date2010-06-11
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR 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 2010-06-11 under 510(k) number K100129. 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, AMBU BLUE SENSOR NEO X?

AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X is a medical device that received FDA 510(k) clearance on 2010-06-11. The listed applicant is Ambu A/S. The 510(k) number is K100129.

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

AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X received FDA 510(k) clearance on 2010-06-11, under 510(k) number K100129.

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

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

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Other records listing Ambu A/S as applicant

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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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