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FDA 510(k)

AEROSET SYSTEM

K-Number: K980367 · 1998-04-01

ApplicantAbbott Laboratories
Decision Date1998-04-01
Product CodeCGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AEROSET SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1998-04-01 under 510(k) number K980367. The device is classified under product code CGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEROSET SYSTEM?

AEROSET SYSTEM is a medical device that received FDA 510(k) clearance on 1998-04-01. The listed applicant is Abbott Laboratories. The 510(k) number is K980367.

When did AEROSET SYSTEM receive FDA 510(k) clearance?

AEROSET SYSTEM received FDA 510(k) clearance on 1998-04-01, under 510(k) number K980367.

Who is the listed applicant for AEROSET SYSTEM?

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

What is the FDA product code for AEROSET SYSTEM?

The FDA product code for AEROSET SYSTEM is CGZ.

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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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