510(k) K930265

HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT by GE Medical Systems — Product Code LNI

K930265 is an FDA 510(k) premarket notification submitted by GE Medical Systems for the device "HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT". The FDA issued a decision of Substantially Equivalent on April 25, 1995. The device falls under product code LNI (System, Nuclear Magnetic Resonance Spectroscopic), a Class II device regulated under 21 CFR 892.1000. GE Medical Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1995
Date Received
January 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Spectroscopic
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type