510(k) K790322

OPTIONAL ACCESSORY FOOT SWITCH MODEL 100 by Applied Medical Research — Product Code EBW

K790322 is an FDA 510(k) premarket notification submitted by Applied Medical Research for the device "OPTIONAL ACCESSORY FOOT SWITCH MODEL 100". The FDA issued a decision of Substantially Equivalent on May 14, 1979. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. Applied Medical Research has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1979
Date Received
February 15, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Foot, Handpiece And Cord
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type