DISPOS. MEDICATION NEBULIZER

Nebulizer (direct Patient Interface)

HOSPITAK, INC.

The following data is part of a premarket notification filed by Hospitak, Inc. with the FDA for Dispos. Medication Nebulizer.

Pre-market Notification Details

Device IDK831270
510k NumberK831270
Device Name:DISPOS. MEDICATION NEBULIZER
ClassificationNebulizer (direct Patient Interface)
Applicant HOSPITAK, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-04-19
Decision Date1983-06-08

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