510(k) K862741

Q50 MEDICAL TREADMILL by Quinton, Inc. — Product Code IOL

K862741 is an FDA 510(k) premarket notification submitted by Quinton, Inc. for the device "Q50 MEDICAL TREADMILL". The FDA issued a decision of Substantially Equivalent on July 29, 1986. The device falls under product code IOL (Treadmill, Powered), a Class I device regulated under 21 CFR 890.5380. Quinton, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1986
Date Received
July 21, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Treadmill, Powered
Device Class
Class I
Regulation Number
890.5380
Review Panel
PM
Submission Type