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510(k) Data Aggregation
K Number
K962087Device Name
SERVOTRONIC EC100 SYSTEM
Manufacturer
Date Cleared
1997-04-23
(330 days)
Product Code
Regulation Number
878.4820Why did this record match?
Applicant Name (Manufacturer) :
MEDICON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Servotronic EC 100 System is intended to be used for high speed cutting, sawing, drilling, and manipulation of soft tissue and bone in microsurgical procedures including maxillofacial surgery, ENT surgery, orthopedic surgery, and plastic surgery.
Device Description
The Servotronic EC 100 System's primary components are: (1) a control unit with irrigation pump; (2) a micromotor; (3) a foot switch for remote control; and (4) various hand pieces and tools. The hand pieces to be used with the Servotronic EC 100 System include the following: (1) Sachse Micro Oscillating Saw; (2) Sachse Micro Osseoscalpel Saw; (3) Micro Compass Saw; (4) Steinhauser Mucotome; (5) Micro Sagittal Saw; and (6) Hauenstein Angular Screwing Instrument.
The Servotronic EC 100 requires an AC current of 110V or 230/240V. An electrical cord, which is intended to be plugged into a standard electrical outlet, is connected to the back of the control unit. The Servotronic EC 100 has integrated safety and monitoring functions for excess temperature, current limitations within the main supply circuit and within the motor electronics, and a speed-dependent stop used during a change of direction.
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