510(k) K011608

MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL by Medical Advances, Inc. — Product Code MOS

K011608 is an FDA 510(k) premarket notification submitted by Medical Advances, Inc. for the device "MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL". The FDA issued a decision of Substantially Equivalent on Aug 14, 2001. 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
Aug 14, 2001
Date Received
May 25, 2001
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 K011608. Report a data issue: hello@regdatalab.com.