Servotronic EC100 System
FDA 510(k) K972857 · Medicon EG
510(k) numberK972857
Submission
- Device name
- Servotronic EC100 System
- Applicant
- Medicon EG
Washington, DC, US - Received
- August 1, 1997
- Decision date
- January 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Servotronic EC100 System cleared by the FDA?
Servotronic EC100 System (K972857) received a 510(k) decision of Substantially Equivalent on January 16, 1998, 168 days after the submission was received.
What is the product code of K972857?
The FDA product code is HBC – Motor, Drill, Electric, a Class II (moderate risk) device regulated under 21 CFR 882.4360.