The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Model Q55xt Powered Treadmill.
Device ID | K864013 |
510k Number | K864013 |
Device Name: | MODEL Q55XT POWERED TREADMILL |
Classification | Treadmill, Powered |
Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
Contact | Ron R Duck |
Correspondent | Ron R 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 | 1986-10-15 |
Decision Date | 1986-11-14 |