510(k) K902690

SONICAID MODEL MERIDIAN 800 by Oxford Medilog, Inc. — Product Code HGM

K902690 is an FDA 510(k) premarket notification submitted by Oxford Medilog, Inc. for the device "SONICAID MODEL MERIDIAN 800". The FDA issued a decision of Substantially Equivalent on February 5, 1991. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Oxford Medilog, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1991
Date Received
June 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Monitoring, Perinatal
Device Class
Class II
Regulation Number
884.2740
Review Panel
OB
Submission Type