MANIFOLD/NEBULIZER BREATHING PRODUCTS

Set, Tubing And Support, Ventilator (w Harness)

HOSPITAK, INC.

The following data is part of a premarket notification filed by Hospitak, Inc. with the FDA for Manifold/nebulizer Breathing Products.

Pre-market Notification Details

Device IDK791469
510k NumberK791469
Device Name:MANIFOLD/NEBULIZER BREATHING PRODUCTS
ClassificationSet, Tubing And Support, Ventilator (w Harness)
Applicant HOSPITAK, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBZO  
CFR Regulation Number868.5975 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-08-06
Decision Date1979-08-28

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