The following data is part of a premarket notification filed by Medcraft Corp. with the FDA for Treadmill, Diagnostic.
Device ID | K760509 |
510k Number | K760509 |
Device Name: | TREADMILL, DIAGNOSTIC |
Classification | Treadmill, Powered |
Applicant | MEDCRAFT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IOL |
CFR Regulation Number | 890.5380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-24 |
Decision Date | 1976-08-30 |