The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Stress Table/ergometer System.
Device ID | K792591 |
510k Number | K792591 |
Device Name: | STRESS TABLE/ERGOMETER SYSTEM |
Classification | Exerciser, Measuring |
Applicant | VICTOREEN, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | ISD |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-17 |
Decision Date | 1980-01-04 |