MANIFOLD & NEBU. FOR SINGLE LINE MACH.

Nebulizer (direct Patient Interface)

INSPIRON CORP.

The following data is part of a premarket notification filed by Inspiron Corp. with the FDA for Manifold & Nebu. For Single Line Mach..

Pre-market Notification Details

Device IDK772071
510k NumberK772071
Device Name:MANIFOLD & NEBU. FOR SINGLE LINE MACH.
ClassificationNebulizer (direct Patient Interface)
Applicant INSPIRON CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-11-01
Decision Date1977-11-15

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