SALTER AIRE COMPRESSOR

Nebulizer (direct Patient Interface)

SALTER LABS

The following data is part of a premarket notification filed by Salter Labs with the FDA for Salter Aire Compressor.

Pre-market Notification Details

Device IDK992285
510k NumberK992285
Device Name:SALTER AIRE COMPRESSOR
ClassificationNebulizer (direct Patient Interface)
Applicant SALTER LABS 100 W. SYCAMORE RD. Arvin,  CA  93203
ContactDuane Kazal
CorrespondentDuane Kazal
SALTER LABS 100 W. SYCAMORE RD. Arvin,  CA  93203
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-07
Decision Date2000-01-07
Summary:summary

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