The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Medtrack Treadmill.
Device ID | K911751 |
510k Number | K911751 |
Device Name: | MEDTRACK TREADMILL |
Classification | Treadmill, Powered |
Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
Contact | Ron Duck |
Correspondent | Ron Duck QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
Product Code | IOL |
CFR Regulation Number | 890.5380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-18 |
Decision Date | 1991-05-29 |