510(k) K854720

NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM. by Nemectron Medical, Inc. — Product Code IPF

K854720 is an FDA 510(k) premarket notification submitted by Nemectron Medical, Inc. for the device "NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM.". The FDA issued a decision of Substantially Equivalent on March 10, 1986. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Nemectron Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1986
Date Received
November 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type