510(k) K003685

MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL by Medical Advances, Inc. — Product Code MOS

K003685 is an FDA 510(k) premarket notification submitted by Medical Advances, Inc. for the device "MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL". The FDA issued a decision of Substantially Equivalent on Dec 22, 2000. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), 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
Dec 22, 2000
Date Received
Nov 30, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Coil, Magnetic Resonance, Specialty
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type
510(k)

Source: FDA 510(k) database entry for K003685. Report a data issue: hello@regdatalab.com.