The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Quinton Medtrack Cr Plus Treadmill.
Device ID | K990866 |
510k Number | K990866 |
Device Name: | QUINTON MEDTRACK CR PLUS TREADMILL |
Classification | Exerciser, Measuring |
Applicant | QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
Contact | Matthew J Hedlund |
Correspondent | Matthew J Hedlund QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
Product Code | ISD |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-16 |
Decision Date | 1999-04-29 |