The following data is part of a premarket notification filed by Warren E. Collins, Inc. with the FDA for Metabolic Exercise Testing System.
Device ID | K831780 |
510k Number | K831780 |
Device Name: | METABOLIC EXERCISE TESTING SYSTEM |
Classification | Computer, Oxygen-uptake |
Applicant | WARREN E. COLLINS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | BZL |
CFR Regulation Number | 868.1730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-02 |
Decision Date | 1983-09-12 |