510(k) K071094

MODIFICATION TO SOLAR GI by Medical Measurement Systems B.V. — Product Code FFX

K071094 is an FDA 510(k) premarket notification submitted by Medical Measurement Systems B.V. for the device "MODIFICATION TO SOLAR GI". The FDA issued a decision of Substantially Equivalent on Aug 13, 2007. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Medical Measurement Systems B.V. has 6 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 13, 2007
Date Received
Apr 18, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
System, Gastrointestinal Motility (Electrical)
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type
510(k)

Source: FDA 510(k) database entry for K071094. Report a data issue: hello@regdatalab.com.