BE#6006 VAR. RESIS. INSPIR. MUSCLE

Spirometer, Therapeutic (incentive)

INSTRUMENTATION INDUSTRIES, INC.

The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Be#6006 Var. Resis. Inspir. Muscle.

Pre-market Notification Details

Device IDK821492
510k NumberK821492
Device Name:BE#6006 VAR. RESIS. INSPIR. MUSCLE
ClassificationSpirometer, Therapeutic (incentive)
Applicant INSTRUMENTATION INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBWF  
CFR Regulation Number868.5690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-05-18
Decision Date1982-09-24

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