The following data is part of a premarket notification filed by Associated Mills, Inc. with the FDA for Mt-10, Et-20.
Device ID | K800251 |
510k Number | K800251 |
Device Name: | MT-10, ET-20 |
Classification | Treadmill, Mechanical |
Applicant | ASSOCIATED MILLS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IOG |
CFR Regulation Number | 890.5370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-02-06 |
Decision Date | 1980-04-02 |