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FDA 510(k)

HAND HELD NEBULIZER SYSTEM

K-Number: K884947 · 1989-02-17

ApplicantSalter Labs
Decision Date1989-02-17
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HAND HELD NEBULIZER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 1989-02-17 under 510(k) number K884947. 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 HAND HELD NEBULIZER SYSTEM?

HAND HELD NEBULIZER SYSTEM is a medical device that received FDA 510(k) clearance on 1989-02-17. The listed applicant is Salter Labs. The 510(k) number is K884947.

When did HAND HELD NEBULIZER SYSTEM receive FDA 510(k) clearance?

HAND HELD NEBULIZER SYSTEM received FDA 510(k) clearance on 1989-02-17, under 510(k) number K884947.

Who is the listed applicant for HAND HELD NEBULIZER SYSTEM?

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

What is the FDA product code for HAND HELD NEBULIZER SYSTEM?

The FDA product code for HAND HELD NEBULIZER SYSTEM 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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