510(k) K895629

MODEL 8100; UPPER EXTREMITY COIL by Medical Advances, Inc. — Product Code LNH

K895629 is an FDA 510(k) premarket notification submitted by Medical Advances, Inc. for the device "MODEL 8100; UPPER EXTREMITY COIL". The FDA issued a decision of Substantially Equivalent on Feb 2, 1990. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Medical Advances, Inc. has 56 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 2, 1990
Date Received
Sep 19, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type
510(k)

Source: FDA 510(k) database entry for K895629. Report a data issue: hello@regdatalab.com.