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FDA 510(k)

HOPE NEBULIZER

K-Number: K980407 · 1998-05-27

ApplicantB&B Medical Technologies, Inc.
Decision Date1998-05-27
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HOPE NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is B&B Medical Technologies, Inc.. It received FDA 510(k) clearance on 1998-05-27 under 510(k) number K980407. 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 HOPE NEBULIZER?

HOPE NEBULIZER is a medical device that received FDA 510(k) clearance on 1998-05-27. The listed applicant is B&B Medical Technologies, Inc.. The 510(k) number is K980407.

When did HOPE NEBULIZER receive FDA 510(k) clearance?

HOPE NEBULIZER received FDA 510(k) clearance on 1998-05-27, under 510(k) number K980407.

Who is the listed applicant for HOPE NEBULIZER?

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

What is the FDA product code for HOPE NEBULIZER?

The FDA product code for HOPE NEBULIZER is CAF.

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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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