510(k) K945242

NERVE MONITOR ELECTRODES/STIMULATOR PROBES by Micromed Development Corp. — Product Code ETN

K945242 is an FDA 510(k) premarket notification submitted by Micromed Development Corp. for the device "NERVE MONITOR ELECTRODES/STIMULATOR PROBES". The FDA issued a decision of Substantially Equivalent on December 27, 1994. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Micromed Development Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1994
Date Received
October 27, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve
Device Class
Class II
Regulation Number
874.1820
Review Panel
EN
Submission Type