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FDA 510(k)

AERONEB II, MODEL APN 200

K-Number: K992831 · 2000-08-25

ApplicantAerogen, Inc.
Decision Date2000-08-25
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AERONEB II, MODEL APN 200 is the device name listed in this FDA 510(k) record. The listed applicant is Aerogen, Inc.. It received FDA 510(k) clearance on 2000-08-25 under 510(k) number K992831. 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 AERONEB II, MODEL APN 200?

AERONEB II, MODEL APN 200 is a medical device that received FDA 510(k) clearance on 2000-08-25. The listed applicant is Aerogen, Inc.. The 510(k) number is K992831.

When did AERONEB II, MODEL APN 200 receive FDA 510(k) clearance?

AERONEB II, MODEL APN 200 received FDA 510(k) clearance on 2000-08-25, under 510(k) number K992831.

Who is the listed applicant for AERONEB II, MODEL APN 200?

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

What is the FDA product code for AERONEB II, MODEL APN 200?

The FDA product code for AERONEB II, MODEL APN 200 is CAF.

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Other records listing Aerogen, 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.

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Related Devices (Code: CAF)

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.

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Official Source

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