CHAMBER, AEROBIC

System, Transport, Aerobic

MARION LABORATORIES, INC.

The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Chamber, Aerobic.

Pre-market Notification Details

Device IDK780440
510k NumberK780440
Device Name:CHAMBER, AEROBIC
ClassificationSystem, Transport, Aerobic
Applicant MARION LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJTW  
CFR Regulation Number866.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-03-20
Decision Date1978-04-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.