The following data is part of a premarket notification filed by Tri-tech, Inc. with the FDA for Stairmaster Model 6000 Ergometer.
Device ID | K912140 |
510k Number | K912140 |
Device Name: | STAIRMASTER MODEL 6000 ERGOMETER |
Classification | Exerciser, Measuring |
Applicant | TRI-TECH, INC. C/O RICHARD HAMER ASSOC.INC. P.O.BOX 16598 Fort Woth, TX 76162 |
Contact | Richard A.hamer |
Correspondent | Richard A.hamer TRI-TECH, INC. C/O RICHARD HAMER ASSOC.INC. P.O.BOX 16598 Fort Woth, TX 76162 |
Product Code | ISD |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-14 |
Decision Date | 1991-12-17 |