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FDA 510(k)

SALTER LABS 8990 SERIES NEBULIZER

K-Number: K962085 · 1996-08-26

ApplicantSalter Labs
Decision Date1996-08-26
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SALTER LABS 8990 SERIES NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 1996-08-26 under 510(k) number K962085. 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 SALTER LABS 8990 SERIES NEBULIZER?

SALTER LABS 8990 SERIES NEBULIZER is a medical device that received FDA 510(k) clearance on 1996-08-26. The listed applicant is Salter Labs. The 510(k) number is K962085.

When did SALTER LABS 8990 SERIES NEBULIZER receive FDA 510(k) clearance?

SALTER LABS 8990 SERIES NEBULIZER received FDA 510(k) clearance on 1996-08-26, under 510(k) number K962085.

Who is the listed applicant for SALTER LABS 8990 SERIES NEBULIZER?

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 SALTER LABS 8990 SERIES NEBULIZER?

The FDA product code for SALTER LABS 8990 SERIES NEBULIZER is CAF.

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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

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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