510(k) K883650

INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110 by Instrumentarium Corp. — Product Code LNH

K883650 is an FDA 510(k) premarket notification submitted by Instrumentarium Corp. for the device "INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110". The FDA issued a decision of Substantially Equivalent on September 16, 1988. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Instrumentarium Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1988
Date Received
August 29, 1988
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