The following data is part of a premarket notification filed by Battle Creek Equipment Co. with the FDA for Standard Health Bike Model 019.
Device ID | K791866 |
510k Number | K791866 |
Device Name: | STANDARD HEALTH BIKE MODEL 019 |
Classification | Exerciser, Measuring |
Applicant | BATTLE CREEK EQUIPMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ISD |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-09-21 |
Decision Date | 1979-10-04 |