EMS Kermit

FDA 510(k) K992504 · (Ems Sa) Electro Medical Systems

Substantially Equivalent

510(k) numberK992504

Submission

Device name
EMS Kermit
Applicant
(Ems Sa) Electro Medical Systems
North Attleboro, MA, US
Received
July 27, 1999
Decision date
January 27, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ELC – Scaler, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4850
Specialty
Dental

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Questions and answers

When was EMS Kermit cleared by the FDA?

EMS Kermit (K992504) received a 510(k) decision of Substantially Equivalent on January 27, 2000, 184 days after the submission was received.

What is the product code of K992504?

The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.