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FDA 510(k)

AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C

K-Number: K053360 · 2006-03-23

ApplicantAerovectrx Corporation
Decision Date2006-03-23
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C is the device name listed in this FDA 510(k) record. The listed applicant is Aerovectrx Corporation. It received FDA 510(k) clearance on 2006-03-23 under 510(k) number K053360. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C?

AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C is a medical device that received FDA 510(k) clearance on 2006-03-23. The listed applicant is Aerovectrx Corporation. The 510(k) number is K053360.

When did AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C receive FDA 510(k) clearance?

AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C received FDA 510(k) clearance on 2006-03-23, under 510(k) number K053360.

Who is the listed applicant for AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C?

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

What is the FDA product code for AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C?

The FDA product code for AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C is CAF.

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Official Source

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