SPIROCARE 108-B

Spirometer, Therapeutic (incentive)

MARION LABORATORIES, INC.

The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Spirocare 108-b.

Pre-market Notification Details

Device IDK782016
510k NumberK782016
Device Name:SPIROCARE 108-B
ClassificationSpirometer, Therapeutic (incentive)
Applicant MARION LABORATORIES, 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 Received1978-12-05
Decision Date1978-12-13

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