The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Chamber, Aerobic.
Device ID | K780440 |
510k Number | K780440 |
Device Name: | CHAMBER, AEROBIC |
Classification | System, Transport, Aerobic |
Applicant | MARION LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTW |
CFR Regulation Number | 866.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-03-20 |
Decision Date | 1978-04-10 |